Hồ sơ đã công bố

CÔNG TY TNHH Y TẾ HOÀN MỸ

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Số 02/2022-VBCB/HM

Cộng hòa Xã hội Chủ nghĩa Việt Nam

Độc lập - Tự do - Hạnh phúc

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Thành phố Hồ Chí Minh , ngày 24 tháng 06 năm 2022

VĂN BẢN CÔNG BỐ
TIÊU CHUẨN ÁP DỤNG CỦA TRANG THIẾT BỊ Y TẾ THUỘC LOẠI B
Kính gửi: Sở Y tế TP Hồ Chí Minh

1. Tên cơ sở công bố: CÔNG TY TNHH Y TẾ HOÀN MỸ

Mã số thuế hoặc Số giấy phép thành lập Văn phòng đại diện: 0302466774

Địa chỉ: 128 Hồ Văn Huê, Phường 9, Quận Phú Nhuận, TP.Hồ Chí Minh, Phường 09, Quận Phú Nhuận, Thành phố Hồ Chí Minh

Điện thoại cố định: 028.39970518 Fax:  028.39971094

Email: hoanmymedical@gmail.com

2. Người đại diện hợp pháp của cơ sở:

Họ và tên: TRẦN HOÀNG VĂN

Số CMND/Định danh/Hộ chiếu: 022541732   ngày cấp: 24/11/2007   nơi cấp: Công an TP.HCM

Điện thoại cố định: 0918134238   Điện thoại di động:

3. Trang thiết bị y tế công bố tiêu chuẩn áp dụng:

- Tên trang thiết bị y tế: Mũi khoan răng

- Tên thương mại (nếu có): Mũi khoan răng

- Mã Global Medical Device Nomenclature - GMDN (nếu có):

- Chủng loại: Surgical burs; Diamond Burs; Tungsten Carbide Burs; Steel burs

- Mã sản phẩm: Surgical burs (11.104.010; 11.104.014; 11.104.018; 11.104.023; 135.104.100; 136.104.100; 137.104.100; 167IK.204.023; 186RF.104.018; 186RF.204.018; 210IK.16.204.020; 210IK.16.204.028; 210IK.19.205.020; 210IK.19.205.028; 210L.16.204.020; 210L.16.204.028; 210L.20.205.020; 210L.20.205.028; 229.205.025; 229.205.030; 229.205.035; 229.205.040; 229.205.050; 229.205.060; 229.205.080; 229L.205.030; 229L.205.035; 229L.205.040; 229L.205.045; 229L.205.050; 229L.205.060; 229L.205.070; 229L.205.080; 81IK.206.030; 81IK.206.040; C141.104.010; C141.104.014; C141.104.018; C141.104.023; C141.104.025; C141.104.027; C141.104.029; C141.104.031; C141.104.035; C141.104.040; C141.104.050; C141.105.027; C141.105.029; C141.105.031; C141.105.035; C141.105.040; C141.105.050; C141.205.010; C141.205.014; C141.205.018; C141.205.023; C141.205.025; C141.205.027; C141.205.029; C141.205.031; C141.205.035; C141.205.040; C141.205.050; C141.206.010; C141.206.014; C141.206.018; C141.206.023; C141.206.025; C141.206.027; C141.206.029; C141.206.031; C141.206.035; C141.206.040; C141.206.050; C141.207.027; C141.316.010; C141.316.012; C141.316.014; C141.316.016; C141.316.018; C141.316.021; C141.316.023; C141A.104.023; C141A.104.027; C141A.104.031; C141A.104.035; C141A.104.040; C141A.104.050; C141A.205.023; C141A.205.027; C141A.205.031; C141A.205.035; C141A.205.040; C141A.205.050; C141A.206.023; C141A.206.027; C141A.206.031; C141A.206.035; C141A.206.040; C141A.206.050; C141AC.104.023; C141AC.104.027; C141AC.104.031; C141AC.104.035 C141AC.104.040; C141AC.104.050; C141AC.205.023; C141AC.205.027; C141AC.205.031; C141AC.205.035; C141AC.205.040; C141AC.206.023; C141AC.206.027; C141AC.206.031; C141AC.206.035; C141AC.206.040; C151.316.015; C151.317.015; C157.316.011; C157.316.016; C161.104.016; C161.205.016; C161.206.016; C161.316.016; C162.104.016; C162.205.016; C162.206.016; C162.316.016; C162A.104.016; C162A.206.016; C162A.316.016; C162A.317.016; C162AAC.316.016; C162A.316.016; C162AC.316.016; C162S.104.016; C162S.206.016; C162S.316.016; C162SAC.316.016; C163A.104.014; C163A.205.014; C166.104.021; C166.205.021; C166.206.021;C166A.104.021; C166A.206.021; C166SAC.104.021; C167.104.023; C167.206.023; C254.316.010; C254.316.012; C254.317.010; C254.317.012; C254A.104.012; C254A.205.012; C254A.206.012; C254A.316.012; C254A.317.012; C254AAC.316.012; C254AAC.317.012; C255A.104.012; C255A.206.012; C255A.317.012; C262.104.016; C262.206.016; C262.316.016; C262.317.016; C267.316.016; C267.317.016; C269.104.016; C269.206.016; C269.316.016; C269.317.016; C269GK.316.016; C269GK.317.016; C269GKS.314.016; C560.317.008; D254.317.016; D254T.317.016; G254.317.014;G254T.317.014; GSD1.104.021; GSD1.104.023; GSD1.204.018; GSD1.204.021; GSD1.204.023; GSD1.314.016; GSD1.314.018; GSD1.314.021; GSD1T.315.016; GSD1T.315.018; GSD1T.315.021; RF161.104.016; RF161.205.016; RF161.316.016; RF162.104.016; RF162.205.016; RF162.316.016; RF163.104.014; RF163.205.014; RF165.104.023; RF166.104.021; RF166.205.021; RF167.104.023; RF167.205.023; RF168.105.023; RF168.206.023; RF169.106.023; RFA.316.016; RFB.316.016; RFC.316.016; STT249.314.016; STT250.314.016) Diamond Burs (368.314.010; 368.314.016; 368.314.018; 368.314.023; 369.314.025; 379.314.012; 379.314.014; 379.314.016; 379.314.018; 379.314.023; 379.314.029; 390.314.016; 392.314.016; 40001SO; 40002SO; 40003SO; 40004SO; 40005SO; 40006SO; 40007SO; 400035SO; 40100SO; 655.314.018; 801.314.007; 801.314.008; 801.314.009; 801.314.010; 801.314.012; 801.314.014; 801.314.016; 801.314.018; 801.314.021; 801.314.023; 801.314.025; 801.314.029; 801.314.035; 801.314.042; 801.316.010; 801.316.012; 801.316.014; 801.316.016; 801.316.018; 801.316.023; 801L.314.014; 801L.314.016; 801L.314.023; 801L.314.029; 802.314.008; 802.314.009; 802.314.010; 802.314.012; 802.314.014; 802.314.016; 802.314.018; 802.314.023; 802L.314.013; 802L.314.016; 802L.314.021; 805.314.008; 805.314.009; 805.314.010; 805.314.012; 805.314.014; 805.314.016; 805.314.018; 805.314.021; 805.314.023; 806.314.009; 806.314.010; 806.314.012; 806.314.014; 806.314.016; 806.314.018; 807.314.010; 807.314.012; 807.314.014; 807.314.016; 807.314.018; 807.314.021; 807.314.023; 807L.314.018; 808.314.018; 808.314.023; 811.314.033; 811.314.037; 811.314.047; 813.314.010; 813.314.014; 813.314.016; 813.314.018; 813L.314.014; 813L.314.016; 815.314.012; 815.314.016; 815.314.018; 815.314.027; 817.314.047; 818.314.035; 818.314.040; 818.314.050; 820.314.040; 822.314.008; 822.314.009; 822.314.010; 822.314.012; 825.314.018; 825.314.025; 825.314.040; 825.314.050; 830.314.008; 830.314.009; 830.314.010; 830.314.012; 830.314.014; 830.314.016; 830.314.018; 830.314.021; 830L.314.012; 830L.314.014; 830L.314.016; 830L.314.018; 830L.314.021; 830L.314.025; 833.314.018; 833.314.021; 833.314.031; 834.314.016; 834.314.021; 834A.314.031; 835.314.007; 835.314.008; 835.314.009; 835.314.010; 835.314.012; 835.314.014; 835.314.016; 835.314.018; 835KR.314.008; 835KR.314.010; 835KR.314.012; 835KR.314.014; 836.314.008; 836.314.010; 836.314.012; 836.314.014; 836.314.016; 836.314.018; 836KR.314.008; 836KR.314.010; 836KR.314.012;836KR.314.014; 836KR.314.016; 837.314.010; 837.314.012; 837.314.014; 837.314.016; 837.314.018; 837KR.314.010; 837KR.314.012; 837KR.314.014; 837KR.314.016; 837KR.314.018; 837L.314.010 L 837L.314.012; 837L.314.014; 837L.314.016; 837L.314.018; 838.314.008; 838.314.009; 838.314.010; 838.314.012; 838.314.014; 839.314.010; 839.314.012; 839.314.014; 839.314.016; 840.314.010; 840.314.012; 840.314.014; 840.314.016; 842.314.012; 842.314.014; 845.314.009; 845.314.010; 845.314.012; 845.314.014; 845.314.016; 845KR.314.018; 845KR.314.025; 846.314.012; 846.314.016; 846KR.314.016; 847.314.010; 847.314.012; 847.314.014; 847.314.016; 847.314.018; 847.314.023; 847KR.314.016; 847KR.314.023; 848.314.010; 848.314.012; 848.314.014; 848.314.016; 848.314.018; 848.314.023; 848L.314.012; 848L.314.014; 848L.314.016; 848L.314.018; 848L.314.021; 849.314.009; 849.314.010; 849.314.012; 850.314.010; 850.314.012; 850.314.014; 850.314.016; 850.314.018; 850.314.023; 850.314.031; 850KR.314.014; 850KR.314.018; 850L.314.012; 850L.314.014; 850L.314.016; 850L.314.018; 851.314.010; 851.314.012; 851.314.016; 852.314.010; 852.314.012; 852.314.023; 855.314.012; 855.314.014; 855.314.025; 856.314.009; 856.314.010; 856.314.012; 856.314.014; 856.314.016; 856.314.018; 856.314.021; 856.314.025; 856L.314.014; 856L.314.016; 856L.314.018; 856L.314.020; 857.314.012; 857.314.014; 857.314.016; 858.314.010; 858.314.012; 858.314.014; 858.314.016; 858.314.018; 859.314.010; 859.314.012; 859.314.014; 859.314.016; 859.314.018; 859.314.021; 859L.314.010; 859L.314.014; 859L.314.016; 859L.314.018; 860.314.010; 860.314.012; 860.314.014; 860.314.016; 861.314.012; 861.314.014; 861SE.314.012; 862.314.009; 862.314.010; 862.314.012; 862.314.014; 862.314.016; 862.314.018; 862.314.021; 863.314.010; 863.314.012; 863.314.014; 863.314.016; 863.314.018; 863L.314.016; 863SE.314.012; 864.314.012; 864.314.014; 864.314.016; 864.314.018; 868A.314.018; 868A.314.021; 874.314.009; 874K.314.010; 875.314.009; 875.314.010; 875K.314.012; 876.314.009; 876K.314.012; 877.314.009; 877.314.010; 877.314.012; 877K.314.012; 878.314.008; 878.314.009; 878.314.010; 878.314.012; 878.314.014; 878.314.016; 878.314.018; 878K.314.012; 878K.314.014; 878K.314.016; 878K.314.018; 878K.314.021; 879.314.010; 879.314.012; 879.314.014; 879.314.016; 879.314.018; 879K.314.012; 879K.314.014; 879K.314.016; 879K.314.018; 879K.314.021; 879L.314.012; 879L.314.014; 880.314.010; 880.314.012; 880.314.014; 880.314.016; 881.314.010; 881.314.012; 881.314.014; 881.314.016; 881.314.018; 882.314.012; 882.314.014; 883.314.010; 884.314.010; 885.314.008; 885.314.010; 885.314.012; 885.314.014; 885.314.016; 886.314.010; 886.314.012; 886.314.014; 886.314.016; 888.314.012; 889.314.009; 889.314.010; 898.314.016; 899.314.021; 899.314.027; 899.314.031; 909.314.027; 909.314.037; 909.314.040; 909.314.055; 970.313.023; 980.313.027; 986.314.041; 998.314.026; C368.314.010; C368.314.016; C368.314.018; C368.314.023; C369.314.025; C379.314.012; C379.314.014; C379.314.016; C379.314.018; C379.314.023; C379.314.029; C390.314.016; C392.314.016; C801.314.012; C801.314.014; C801.314.016; C801.314.018; C801.314.021; C801.314.023; C801.314.025; C801.314.029; C801.314.035; C830.314.012; C830L.314.014; C833.314.021; C833.314.031; C847.314.010; C848.314.010; C848.314.012; C848.314.014; C848.314.016; C850.314.010; C850.314.012; C850.314.014; C850.314.016; C850.314.018; C850L.314.014; C852.314.010; C852.314.012; C856.314.010; C856.314.012; C856.314.016; C858.314.010; C858.314.012; C858.314.014; C858.314.016; C859.314.010; C859.314.012; C859.314.014; C859.314.016; C859.314.018; C859L.314.010; C859L.314.014; C859L.314.016; C860.314.010; C860.314.012; C861.314.012; C862.314.009; C862.314.010; C862.314.012; C862.314.014; C862.314.016; C863.314.010; C863.314.012; C863.314.014; C863.314.016; C864.314.016; C878.314.010; C878.314.014; C879.314.012; C879.314.014; C879.314.016; C881.314.012; C881.314.014; C882.314.012; C889.314.009; C889.314.010; C972.315.020; C986.314.026; C986.314.031; C986.314.041; F368.314.010; F368.314.016; F368.314.018; F368.314.023; F369.314.025; F370.314.023; F379.314.012; F379.314.014; F379.314.016; F379.314.018; F379.314.023; F379.314.029; F390.314.016; F392.314.016; F801.314.007; F801.314.008; F801.314.009; F801.314.010; F801.314.012; F801.314.014; F801.314.016; F801.314.018; F801.314.021; F801.314.023; F801.314.025; F801.314.029; F801.314.035; F802.314.016; F805.314.014; F822.314.012; F830.314.010; F830.314.012; F830.314.014; F830L.314.012; F830L.314.014; F830L.314.016; F833.314.018; F833.314.021; F833.314.031; F835.314.010; F835KR.314.012; F836.314.010; F836.314.012; F836KR.314.010; F836KR.314.012; F837.314.012; F837.314.014; F837KR.314.010; F837KR.314.012; F837KR.314.014; F837KR.314.016; F837L.314.012; F839.314.010; F839.314.014; F845KR.314.016; F845KR.314.018; F845KR.314.025; F846KR.314.016; F847.314.010; F847.314.012; F847.314.014; F847.314.016;F847KR.314.016;F847KR.314.023; F848.314.010; F848.314.012; F848.314.014; F848.314.016; F848.314.018; F849.314.012; F850.314.010; F850.314.012; F850.314.014; F850.314.016; F850.314.018; F850.314.023; F850L.314.012; F850L.314.014; F851.314.010; F851.314.012; F852.314.010; F852.314.012; F856.314.009; F856.314.010; F856.314.012; F856.314.014; F856.314.016; F856.314.018; F856.314.021; F856.314.025; F856L.314.014; F856L.314.016; F856L.314.018; F856L.314.020; F857.314.014; F858.314.010; F858.314.012; F858.314.014; F858.314.016; F859.314.010; F859.314.012; F859.314.014; F859.314.016; F859.314.018; F859L.314.010; F859L.314.014; F859L.314.016; F860.314.010; F860.314.012; F860.314.014; F861.314.012; F862.314.009; F862.314.010; F862.314.012; F862.314.014; F862.314.016; F863.314.010; F863.314.012; F863.314.014; F863.314.016; F863.314.018; F864.314.012; F864.314.014; F864.314.016; F877.314.010; F877.314.012; F878.314.008; F878.314.010; F878.314.012; F878.314.014; F878.314.016; F878K.314.014; F878K.314.016; F878K.314.018; F878K.314.021; F879.314.010; F879.314.012; F879.314.014; F879.314.016; F879.314.018; F879K.314.012; F879K.314.014; F879K.314.016;F879K.314.018; F879L.314.012; F879L.314.014; F880.314.012; F880.314.014; F881.314.010; F881.314.012; F881.314.014; F881.314.016; F881.314.018; F882.314.012; F882.314.014; F885.314.010; F885.314.012; F885.314.014; F886.314.012; F886.314.014; F886.314.016; F888.314.012; F889.314.009; F889.314.010; F898.314.016; F899.314.021; F899.314.027; F970.313.023; F972.315.020; F980.313.027; F985.313.031; F986.314.026; F986.314.031; F986.314.041; F998.314.016; F998.314.021; F998.314.023; G368.314.016; G368.314.018; G368.314.023; G369.314.025; G370.314.023; G379.314.012; G379.314.014; G379.314.016; G379.314.018; G379.314.023; G379.314.029; G653.314.018; G654.314.018; G656.314.018; G801.314.009; G801.314.010; G801.314.012; G801.314.014; G801.314.016; G801.314.018; G801.314.021; G801.314.023; G801.314.025; G801.314.029; G801.314.035; G801.314.042; G801.316.014; G801.316.016; G801.316.018; G801.316.023; G801L.314.014; G801L.314.016; G801L.314.023; G801L.314.029; G802.314.012; G802.314.014; G802.314.016; G802.314.018; G802.314.023; G805.314.012; G805.314.014; G805.314.016; G805.314.018; G805.314.021; G806.314.010; G806.314.012; G806.314.014; G806.314.016; G806.314.018; G806.314.023; G807.314.012; G807.314.014; G807.314.016; G807.314.018; G807.314.021; G811.314.033; G811.314.037; G811.314.047; G813.314.014; G813.314.016; G813L.314.014; G813L.314.016; G815.314.018; G815.314.023; G815.314.027; G817.314.047; G818.314.040; G818.314.050; G822.314.008; G822.314.009; G822.314.010; G822.314.012; G830.314.010; G830.314.012; G830.314.014; G830.314.016; G830.314.018; G830.314.021; G830L.314.012; G830L.314.014; G830L.314.016; G830L.314.018; G830L.314.021; G830L.314.025; G835.314.009; G835.314.010; G835.314.012; G835.314.014; G835.314.016; G835.314.018; G835KR.314.010; G835KR.314.012; G835KR.314.014; G835KR.314.016; G836.314.010; G836.314.012; G836.314.014; G836.314.016; G836.314.018; G836KR.314.010; G836KR.314.012; G836KR.314.014; G836KR.314.016; G837.314.010; G837.314.012; G837.314.014; G837.314.016; G837.314.018; G837KR.314.010; G837KR.314.012; G837KR.314.014; G837KR.314.016; G837L.314.010; G837L.314.012; G837L.314.014; G837L.314.016; G837L.314.018; G838.314.010; G838.314.012; G838.314.014; G842.314.012; G842.314.014; G842.314.018; G845.314.012; G845.314.014; G845KR.314.016; G845KR.314.018; G845KR.314.025; G846.314.012; G846.314.016; G846.314.025; G846KR.314.016; G846S.314.025; G847.314.010; G847.314.012; G847.314.014; G847.314.016; G847.314.018; G847.314.023; G847KR.314.016; G847KR.314.023; G848.314.010; G848.314.012; G848.314.014; G848.314.016; G848.314.018; G848.314.023; G848L.314.014; G848L.314.016; G848L.314.018; G849.314.012; G849.314.016; G849.314.025; G850.314.010; G850.314.012; G850.314.014; G850.314.016; G850.314.018; G850.314.023; G850.314.031; G850KR.314.014; G850KR.314.018; G850L.314.012; G850L.314.014; G850L.314.016; G850L.314.018; G851.314.012; G851.314.016; G852.314.012; G852.314.023; G855.314.012; G855.314.014; G855.314.025; G856.314.012; G856.314.014; G856.314.016; G856.314.018; G856.314.021; G856.314.025; G856L.314.014; G856L.314.016; G856L.314.018; G856L.314.020; G857.314.012; G857.314.014; G857.314.016; G858.314.010; G858.314.012; G858.314.014; G858.314.016; G858.314.018; G859.314.010; G859.314.012; G859.314.014; G859.314.016; G859.314.018; G859.314.021; G859L.314.014; G859L.314.016; G859L.314.018; G860.314.010; G860.314.012; G860.314.014; G860.314.016; G861.314.012; G861.314.014; G862.314.010; G862.314.012; G862.314.014; G862.314.016; G862.314.018; G863.314.012; G863.314.014; G863.314.016; G863.314.018; G863.314.021; G863L.314.016; G864.314.014; G864.314.016; G864.314.018; G877.314.012; G878.314.010; G878.314.012; G878.314.014; G878.314.016; G878.314.018; G878K.314.012; G878K.314.014; G878K.314.016; G878K.314.018; G878K.314.021; G879.314.010; G879.314.012; G879.314.014; G879.314.016; G879.314.018; G879K.314.012; G879K.314.014; G879K.314.016; G879K.314.018; G879K.314.021; G879K.314.023; G879L.314.012; G879L.314.014 G880.314.012; G880.314.014; G881.314.010; G881.314.012; G881.314.014; G881.314.016; G880.314.018; G882.314.012; G882.314.014; G883.314.010; G884.314.012; G885.314.012; G885.314.014; G885.314.016; G886.314.012; G886.314.014; G886.314.016; G888.314.012; G889.314.009; G889.314.010; G898.314.016; G899.314.021; G899.314.027; G899.314.031; G909.314.037; G909.314.040; GF844.314.014; GF844.314.016; KS0.314.010; KS0F.314.010; KS1.314.012; KS1L.314.012; KS2.314.014; KS3.314.016; S801.313.014; S805.313.012; S845.313.012; S879.313.014; SG368.314.016; SG368.314.018; SG368.314.023; SG379.314.016; SG379.314.018; SG379.314.023; SG379.314.029; SG652.314.018; SG655.314.018; SG656.314.018; SG801.314.012; SG801.314.014; SG801.314.016; SG801.314.018; SG801.314.021; SG801.314.023; SG801.314.025; SG801.314.029; SG801.314.035; SG801.316.016; SG801.316.016; SG801.316.018; SG801L.314.014; SG801L.314.016; SG801L.314.023; SG801L.314.029; SG802.314.014; SG802.314.016; SG802.314.018; SG805.314.014; SG805.314.016; SG805.314.018; SG805.314.021; SG806.314.014; SG806.314.016; SG806.314.018; SG807.314.016; SG811.314.033; SG811.314.037; SG811.314.047; SG813.314.018; SG822.314.012; SG830.314.012; SG830.314.014; SG830.314.016; SG830L.314.014; SG830L.314.016; SG830L.314.018; SG830L.314.021; SG830L.314.025; SG835.314.010; SG835.314.012; SG835.314.014; SG835.314.016; SG835KR.314.014; SG836.314.012; SG836.314.014; SG836.314.016; SG836.314.027; SG836KR.314.014; SG837.314.012; SG837.314.014; SG837.314.016; SG837.314.018; SG837KR.314.012; SG837KR.314.014; SG837KR.314.016; SG837L.314.014; SG837L.314.016; SG838.314.012; SG842.314.012; SG842.314.014; SG847.314.014; SG847.314.016; SG847.314.018; SG848.314.016; SG848.314.018; SG848.314.023; SG848L.314.014; SG848L.314.016; SG848L.314.018; SG850.314.014; SG850.314.016; SG850.314.018; SG850.314.023; SG850KR.314.014; SG850KR.314.018; SG850L.314.014; SG850L.314.016; SG850KR.314.018; SG852.314.037; SG855.314.014; SG855.314.025; SG856.314.012; SG856.314.016; SG856.314.018; SG856.314.021; SG856.314.025; SG856L.314.014; SG856L.314.016; SG856L.314.018; SG856L.314.020; SG857.314.014; SG858.314.014; SG858.314.016; SG858.314.018; SG859.314.018; SG859L.314.016; SG859L.314.018; SG860.314.014; SG862.314.012; SG862.314.014; SG862.314.016; SG862.314.018; SG863.314.012; SG863.314.016; SG863.314.018; SG863.314.021; SG864.314.016; SG864.314.018; SG878.314.012; SG878.314.014; SG878.314.016; SG878K.314.012; SG878K.314.012; SG878K.314.014; SG878K.314.016; SG878K.314.018; SG878K.314.021; SG879.314.012; SG879.314.014; SG879.314.016; SG879.314.018; SG879K.314.012; SG879K.314.014; SG879K.314.016; SG879K.314.018; SG879K.314.021; SG879L.314.012; SG879L.314.014; SG880.314.014; SG881.314.014; SG881.314.016; SG881.314.018; SG881KS.314.012; SG881KS.314.014; SG881KS.314.015; SG881KS.314.016; SG882.314.014; SG885.314.012; SG885.314.014; SG885.314.018; SG886.314.012; SG886.314.014; SG886.314.016; SG889.314.010; SG899.314.021; SG899.314.027; SG899.314.031; SG909.314.040; SG998.314.016; SG998.314.021; SG998.314.023; TM05.314.009; TM10.314.009 ' TM15.314.009; TM20.314.009; UF368.314.023; UF859.314.010; UF859.314.016; UF862.314.010; UF863.314.012; BA001.313.007; BA010.313.008; BA019.313.010; BA108.313.008; BA137.313.007; BA138.313.007; BA160.313.007; BA171.313.012; BA274.313.007; BA277.313.009; BA294.313.007; BA295.313.007; SET/BA; A837.314.014; A842.314.018; A847.314.016; A848.314.018; A848.314.025; AL847.314.016; AL848.314.018; AL848.314.025; AX830.314.012; AX835KR.314.014; AX836KR.314.014; AX845.314.016; AX847.314.018; AX878.314.012; AX878.314.014; AX879.314.012; AX879.314.014; AX879.314.016; 40010SO; 40020SO; FV368.314.020; FV801.314.014; FV801.314.021; FV830L.314.012; FV835KR.314.012; FV850.314.012; FV863.314.012; FV863.314.016; FV877K.314.016; FV878.314.012; FV878.314.014; FV878K.314.022; FV879.314.014; FV879K.314.012; FV879K.314.016; FV881.314.014; FW368.314.020; FW379.314.023; FW801.314.014; FW801.314.021; FW830L.314.012; FW830L.314.014; FW830L.314.016; FW835KR.314.012; FW837KR.314.014; FW847KR.314.016; FW850.314.012; FW860.314.012; FW863.314.012; FW863.314.016; FW877K.314.012; FW877K.314.016; FW878.314.010; FW878.314.012; FW878.314.014; FW878K.314.014; FW878K.314.016; FW878K.314.018; FW878K.314.020; FW878K.314.022; FW879.314.014; FW879K.314.012; FW879K.314.014; FW879K.314.016; FW879K.314.018; FW880.314.012; FW881.314.014; FW881.314.016; FW899.314.027; GV368.314.020; GV368.314.023; GV379.314.023; GV801.314.014; GV801.314.021; GV801.314.023; GV811.314.033; GV830L.314.012; GV830L.314.014; GV830L.314.016; GV835KR.314.012; GV837KR.314.014; GV847.314.014; GV847.314.016; GV847KR.314.016; GV847KR.314.018; GV848.314.018; GV850.314.012; GV850.314.014; GV850.314.016; GV855.314.025; GV856.314.014; GV856.314.016; GV856.314.018; GV856.314.021; GV856L.314.018; GV858.314.014; GV862.314.014; GV863.314.012; GV863.314.016; GV877K.314.012; GV877K.314.016; GV878.314.012; GV878.314.014; GV878K.314.014; GV878K.314.016; GV878K.314.018; GV878K.314.020; GV878K.314.022; GV879.314.014; GV879K.314.012; GV879K.314.014; GV879K.314.016; GV879K.314.018; GV880.314.012; GV881.314.014; GV881.314.016; GV909.314.040; GW368.314.020; GW368.314.023; GW379.314.023; GW801.314.014; GW801.314.021; GW801.314.023; GW801.314.033; GW830L.314.012; GW830L.314.014; GW830L.314.016; GW835KR.314.012; GW837KR.314.014; GW847.314.014; GW847.314.016; GW847KR.314.016; GW847KR.314.018; GW848.314.018; GW850.314.012; GW850.314.014; GW850.314.016; GW855.314.025; GW856.314.014; GW856.314.016; GW856.314.018; GW856.314.021; GW856L.314.018; GW858.314.014; GW862.314.014; GW863.314.012; GW863.314.016; GW877K.314.012; GW877K.314.016; GW878.314.012; GW878.314.014; GW878K.314.014; GW878K.314.016; GW878K.314.018; GW878K.314.020; GW878K.314.022; GW879.314.014; GW879K.314.012; GW879K.314.014; GW879K.314.016; GW879K.314.018; GW880.314.012; GW881.314.014; GW881.314.016; GW881.314.027; GW909.314.040; K802L.314.021; K850.314.014; K850.314.016; K856.314.016; K879.314.014; K881.314.012; K881.314.016; K882.314.012; K899.314.031; KC369.314.025; KC801L.314.014; KC856.314.016; KC859L.314.010; KC879.314.014; KC881.314.016; KF369.314.025; KF379L.315.012; KF801L.314.014; KF856.314.016; KF859L.314.010; KF879.314.014; KF881.314.012; KF881.314.016; KT856.314.016; KT881.314.016; KUF369.314.025; KUF801L.314.014; KUF856.314.016; KUF859L.314.010; KUF879.314.014; KUF879.314.016; SGW837KR.314.016; V368.314.020; V801.314.014; V801.314.021; V830L.314.012; V830L.314.014; V830L.314.016; V835KR.314.012; V837KR.314.014; V845KR.314.016; V846KR.314.016; V850.314.012; V850.314.014; V863.314.012; V863.314.016; V878.314.010; V878.314.012; V878.314.014; V878K.314.014; V879.314.014; V879K.314.012; V879K.314.014; V879K.314.016; V880.314.012; V881.314.014; VT830L.314.012; VT830L.314.014; VT850.314.016; VT879.314.014; W368.314.020; W379.314.023; W801.314.014; W801.314.021; W801.314.023; W830L.314.012; W830L.314.014; W830L.314.016; W835KR.314.012; W837KR.314.014; W845KR.314.016; W846KR.314.016; W846KR.314.023; W847.314.016; W847KR.314.016; W850.314.012; W850.314.014; W863.314.012; W863.314.016; W877K.314.012; W877K.314.016; W878.314.010; W878.314.012; W878.314.014; W878K.314.014; W878K.314.016; W878K.314.018; W878K.314.020; W878K.314.022; W879.314.014; W879K.314.012; W879K.314.014; W879K.314.016; W879K.314.018; W880.314.012; W881.314.014; W899.314.027; 368.204.016; 801.204.010; 801.204.012; 801.204.014; 801.204.016; 801.204.018; 801.204.023; 801.204.029; 805.204.010; 805.204.012; 805.204.014; 805.204.016; 831.205.012; 831L.206.012; 832.205.014; 832L.206.014; 835.204.010; 835.204.012; 835.204.014; 835.204.016; 845.204.010; 845.204.014; 847.204.025; 848.204.016; 849.204.016; 850.204.012; 859.204.012; 859.204.016; 860.204.012; 862.204.012; 863.204.012; 863.204.016; 863.204.018; C831.205.012; C831L.206.012; C832.205.014; C832L.206.014; C863.204.012; F831.205.012; F831L.206.012; F832.205.014; F832L.206.014; T811.314.033C; T822.314.012SC; T830L.314.012C; T830L.314.012SC; T830L.314.014C; T830L.314.014SC; T830L.314.0146C; T830L.314.016SC; T830L.314.018SC; T836.314.012SC; T837.314.012C; T837.314.012SC; T837.314.014C; T837.314.016S; T842.314.018C; T846.314.016SC; T848.314.016C; T848.314.016SC; T848L.314.014C; T850.314.012C; T850.314.014C; T850.314.014SC; T850.314.016C; T850.314.016SC; T850.314.018C; T850.314.018SC; T856.314.012C; T856.314.012SC; T859.314.018SC; T863.314.014C; T878.314.012C; T878.314.012SC; T878.314.014C; T878.314.014SC; T878K.314.014C; T878K.314.014SC; T878K.314.016SC; T878K.314.018C; T879.314.012C; T879.314.012SC; T879.314.014C; T879.314.016C; T879K.314.012SC; T879K.314.014C; T879K.314.014SC; T879K.314.016C; T879K.314.016SC; T879L.314.012SC; T879L.314.014SC; T881.314.012C; T881.314.014C; T882.314.012C; T882.314.014C; T886.314.012SC; T886.314.014SC; J801.314.016; J805.314.014; J859.314.016; J862.314.014; J878K.314.016; J879K.314.016; J909.314.045; JG845.314.016; JG848.314.0189; JG877K.314.020) Tungsten Carbide Burs (C1S.314.006; C1S.314.007; C1S.314.008; C1S.314.009; C1S.314.010 C1S.314.012; C1S.314.014; C1S.314.016; C1S.314.018; C1S.314.021; C1S.314.023; C1S.316.010; C1S.316.012; C1S.316.014; C1S.316.016; C1S.316.018; C1S.316.021; C1S.316.023; C1S.317.010; C1S.317.014; C1S.317.018; C2.314.008; C21.314.008; C21.314.009; C21R.314.009; C23R.314.014; C23XR.314.010; C31.314.009; C31.314.016;C31R.314.012;C33L.315.009; C33L.315.016; C34.314.010; C1S.314.010; C34.314.012; C34L.315.010; C34L.315.012; C34LT.315.012; C34LT.315.016; C36RS.314.012; C38R.314.016; C4AK.314.010; C4AK.314.012; C4AKL.315.012; C4AKXL.315.014; C4AKXXL.315.014; C7.314.008; C7L.314.012; C7L.314.014; T21X.314.010; T21X.314.012; T21XR.314.010; T21XR.314.012; T23XR.314.012; T7X.314.012; T7XL.314.012; T7XL.314.014; ZZC34.314.010; C35L.315.012; H1.314.005; H1.314.006; H1.314.008; H1.314.010; H1.314.012; H1.314.014; H1.314.016; H1.314.018; H1.314.021; H1.314.023; H152.314.009; H152.315.009; H2.314.006; H2.314.008; H2.314.010; H2.314.014; H21.314.009; H21.314.010; H21.314.012; H21R.314.008; H21R.314.010; H21R.314.012; H23.314.008; H23.314.009; H23.314.010; H23L.314.009; H23L.314.010; H23L.314.012; H245.314.008; H245PC.314.008; H31.314.009; H31.314.010; H31.314.012; H31PC.314.010; H31R.314.010; H31R.314.012; H31RPC.314.010; H31RPC.314.012; H33.314.009; H33.314.010; H33.314.012; H33.314.016; H33L.314.009; H33LGK.314.009; H7.314.006; H7.314.008; H7.314.010; H7.314.012; H7PC.314.008; C1.204.006; C1.204.008; C1.204.010; C1.204.012; C1.204.014; C1.204.016; C1.204.018; C1.204.021; C1.204.023; C1.204.027; C1S.204.010; C1S.204.012; C1S.204.014; C1S.204.016; C1S.204.018; C1S.204.021; C1S.204.023; C1S.204.025; C1S.204.027; C1S.204.029; C1S.205.012; C1S.205.014; C1S.205.016; C1S.205.018; C1S.205.021; C1S.205.023; C1SDR.204.014; C1SDR.204.016; C1SDR.204.018; C1SX.204.010; C1SX.204.012; C1SX.204.014; C1SX.204.016; C1SX.204.018; C1SX.204.021; C1SX.204.023; C1SX.205.012; C1SX.205.014; C1SX.205.016; C1SX.205.018; C1SX.205.021; C1SX.205.023; C1SXN.204.010; C1SXN.204.012; C1SXN.204.014; C1SXN.204.016; C1SXN.204.018; C1SXN.204.021; C1SXN.204.023; C1SXN.205.010; C1SXN.205.014; C1SXN.205.018; C1SXN.205.023; C2.204.008; C2.204.010; C2.204.012; C2.204.014; C2.204.016; C2.204.018; C21.204.010; C21.204.012; C21.204.014; C21.204.016; C21L.204.010; C21R.204.010; C21R.204.012; C23.204.008; C23.204.010; C23.204.014; C23R.204.012; C23R.204.014; C23R.204.016; C31.204.010; C31.204.012; C31.204.014; C31.204.018; C31R.204.012; C33.204.012; C7.204.008; C7.204.012; C7L.204.010; C7L.204.012; C7L.204.014; C22AGK.314.016; C22ALGK.315.016; C22GK.314.016; T379X.204.018; T379X.204.023; TC132.314.008; TC132F.314.008; TC132UF.314.008; TC133.314.010; TC133F.314.010; TC133UF.314.010; TC134.314.014; TC134F.314.014; TC134S.314.014; TC134UF.314.014; TC135.314.014; TC135F.314.014; TC135S.314.014; TC135UF.314.014; TC152N.316.009;TC246.314.009; TC246.314.010; TC246.314.012;TC246LUF.314.012; TC246UF.314.009; TC247.314.007; TC247.314.009; TC247.314.010; TC247.314.012; TC247F.314.007; TC247F.314.009; TC247F.314.010; TC247UF.314.007; TC247UF.314.009; TC247UF.314.010; TC248.314.009; TC248.314.012; TC275.314.010; TC275.314.012; TC280.314.009; TC281K.314.012; TC282.314.009; TC282.314.010; TC282.314.012; TC282K.314.014; TC282K.314.016; TC283.314.010; TC283.314.012; TC283.314.014; TC283K.314.016; TC283K.314.021;TC284.314.014; TC284K.314.018; TC284KN.316.016; TC297.314.012; TC297.314.014; TC30.314.006; TC30.314.008; TC30.314.009; TC30.314.010; TC30.314.012; TC30.314.014; TC300.314.014; TC300.314.021; TC336.314.016; TC375.314.012; TC375.314.014; TC375.314.016; TC375R.314.012; TC375R.314.012; TC375R.314.016; TC375R.314.018; TC375R.314.023; TC377.314.010; TC377.314.012; TC378.314.014; TC378.314.016; TC378N.316.014; TC379.314.012; TC379.314.014; TC379.314.018; TC379.314.023; TC379.317.014; TC379.317.023; TC379F.317.023; TC379G.317.023; TC379GK.314.014; TC379N.316.023; TC379S.314.023; TC379UF.314.014; TC379UF.314.018; TC379UF.314.023; TC379UF.317.014; TC379UF.317.023; TC390.314.014; TC390.314.016; TC390.314.018; TC390S.314.018; TC390UF.314.016; TC41.314.010; TC41.314.012; TC41.314.014; TC41.314.016; TC41.314.018; TC41.314.023; TC41.314.027; TC41.314.031; TC41N.316.023; TC41UF.314.018; TC46.314.012; TC46.314.014; TC46.314.018; TC46.314.023; TC46N.316.014; TC47.314.010; TC47.314.014; TC47.314.018; TC47L.314.010; TC47L.314.012; TC47L.314.014; TC47L.314.016; TC48L.314.010; TC48L.314.012; TC48L.317.014; TC48L.317.023; TC48LF.314.012; TC48LS.314.012; TC48LUF.314.012; TC48LUF.317.014; TC48LUF.317.023; TC49.314.010; TC49.314.012; TC49.314.014; TC50.314.010; TC50.314.018; TC50A.314.010; TC50AF.314.010; TC50AUF.314.010; TC847KRG.314.016; TC850.3.314.014; TC850.4.314.012; TC850.6.314.010; TC851.3.314.010; TC851.K.314.008; TC856G.314.016; C22AGK.204.016; C22ALGK.205.016; T21XR.204.012; TC132.204.008; TC246.204.009; TC246.204.010; TC246.204.012; TC282.204.010; TC282.204.012; TC282K.204.014; TC282K.204.016; TC283.204.012; TC283K.204.016; TC283K.204.021; TC284.204.014; TC379.204.012; TC379.204.014; TC379.204.018; TC379.204.018; TC379UF.204.018; TC379UF.204.023; TC390.204.014; TC390.204.016; TC390.204.018; TC390UF.204.016; TC41.204.010; TC41.204.012; TC41.204.014; TC41.204.016; TC41.204.018; TC41.204.023; TC41.204.027; TC41.204.031; TC41UF.204.018; TC46.204.012; TC46.204.014; TC46.204.018; TC46.204.023; TC50.204.010; TC747.205.010; TC747L.206.010; TC758.204.012; TC758L.206.012) Steel burs ( 1.204.005; 1.204.006; 1.204.007; 1.204.008; 1.204.009; 1.204.010; 1.204.012; 1.204.014; 1.204.016; 1.204.018; 1.204.021; 1.204.023; 1.204.025; 1.204.027; 1.204.029; 1.204.031; 1.204.033; 1.204.035; 1.204.037; 1.204.040; 2.104.006; 2.104.007; 2.104.008; 2.204.006; 2.204.007; 2.204.008; 2.204.009; 2.204.010; 2.204.012; 2.204.014; 2.204.016; 2.204.018; 2.204.021; 2.204.023; 207.204.010; 207.204.012; 207.204.014; 207.204.016; 21.204.008; 21.204.009; 21.204.010; 21.204.012; 21.204.014; 21.204.016; 21.204.018; 21.204.021; 21.204.023; 23.204.008; 23.204.009; 23.204.010; 23.204.012; 23.204.014; 23.204.016; 23.204.018; 23.204.021; 23.204.023; 3.204.006; 3.204.007; 3.204.008; 3.204.009; 3.204.010; 3.204.012; 3.204.014; 3.204.016; 3.204.018; 3.204.021; 3.204.023; 36.204.006; 36.204.007; 36.204.008; 36.204.009; 36.204.010; 36.204.012; 36.204.014; 36.204.016; 36.204.018; 36.204.021; 36.204.023; 38.204.007; 38.204.008; 38.204.009; 38.204.010; 38.204.012; 38.204.014; 38.204.016; 38.204.018; 38.204.021; 38.204.023 )

- Quy cách đóng gói (nếu có):

- Loại trang thiết bị y tế: TTBYT Loại B

- Mục đích sử dụng: Sử dụng trong công tác khoan răng trong điều trị nha khoa

- Tên cơ sở sản xuất: EDENTA ETABLISSEMENT

- Địa chỉ cơ sở sản xuất: Industriestrasse 13, 9486 Schaanwald, Liechtenstein,

- Tiêu chuẩn chất lượng sản phẩm áp dụng: ISO 13485:2016

4. Đối với trang thiết bị y tế chứa chất ma túy, tiền chất (nếu có):

- Tên chất ma túy, tiền chất:

- Tên khoa học:

- Mã thông tin CAS:

- Nồng độ, hàm lượng:

- Tổng hàm lượng trong một đơn vị đóng gói nhỏ nhất:

5. Thông tin về chủ sở hữu trang thiết bị y tế:

- Tên chủ sở hữu: EDENTA ETABLISSEMENT

- Địa chỉ chủ sở hữu: Industriestrasse 13, 9486 Schaanwald, Liechtenstein,

6. Thông tin về cơ sở bảo hành:

- Tên cơ sở: Công ty TNHH Y tế Hoàn Mỹ

- Địa chỉ: 128 Hồ Văn Huê, Phường 9, Quận Phú Nhuận ,TP.Hồ Chí Minh, Phường 09, Quận Phú Nhuận, Thành phố Hồ Chí Minh

- Điện thoại cố định: 028.39970518   Điện thoại di động:

7. Số công bố đủ điều kiện sản xuất đối với trang thiết bị y tế sản xuất trong nước:


Hồ sơ kèm theo gồm:

  • Văn bản công bố tiêu chuẩn áp dụng đối với trang thiết bị y tế thuộc loại B
  • Tài liệu mô tả tóm tắt kỹ thuật trang thiết bị y tế bằng tiếng Việt
  • Giấy chứng nhận lưu hành tự do đối với trang thiết bị y tế nhập khẩu


Thông tin về trang thiết bị y tế

Tên trang thiết bị y tế: Mũi khoan răng

Tài liệu kỹ thuật mô tả chức năng, thông số kỹ thuật của trang thiết bị y tế do chủ sở hữu trang thiết bị y tế ban hành: Tài liệu kỹ thuật

Tài liệu hướng dẫn sử dụng của trang thiết bị y tế (Tiếng việt): Tài liệu hướng dẫn sử dụng

Tài liệu hướng dẫn sử dụng của trang thiết bị y tế (Bản gốc): Tài liệu hướng dẫn sử dụng

Mẫu nhãn sẽ sử dụng khi lưu hành tại Việt Nam của trang thiết bị y tế: Mẫu nhãn lưu hành


Cơ sở công bố tiêu chuẩn áp dụng cam kết:

1. Nội dung thông tin công bố là chính xác, hợp pháp và theo đúng quy định. Nếu có sự giả mạo, không đúng sự thật cơ sở xin chịu hoàn toàn trách nhiệm và sẽ bị xử lý theo quy định của pháp luật.

2. Bảo đảm chất lượng và lưu hành trang thiết bị y tế theo đúng hồ sơ đã công bố.

3. Cập nhật các thay đổi liên quan đến hồ sơ công bố tiêu chuẩn áp dụng theo quy định.

Người đại diện hợp pháp của cơ sở

Ký tên (Ghi họ tên đầy đủ, chức danh)