STT Tên thiết bị y tế Chủng loại/mã sản phẩm Hãng/nước sản xuất Hãng/nước chủ sở hữu Mục đích sử dụng theo chỉ định của chủ sở hữu Căn cứ để phân loại mức độ rủi ro Mức độ rủi ro được phân loại
1 Hệ thống khoan cưa (Handpiece) BJ5400, BJ5600, BJ8200, BJ2100, BJ4200, BJ6200 Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Bộ dụng cụ sử dụng trong phẫu thuật xương QT 9 – phần II – Thông tư 39/2016/TT-BYT TTBYT Loại B
2 Thiết bị đính kèm (Attachments) BJ5401, BJ5402, BJ5402SAO, BJ5402B/D/S/SB, BJ5407B/D/S, BJ5410, BJ5411, BJ5413, BJ5613, BJ6201, BJ6203, BJ6207B, BJ8201, BJ8202, BJ8203, BJ8202SAO, BJ8209, BJ8213, BJ2101, BJ2101S, BJ2102, BJ2102SAO, BJ2103, BJ2103B, BJ2103D, BJ2104, BJ2105, BJ2106, BJ2107, BJ2107B, BJ2107D, BJ2109, BJ2110, BJ2111, BJ2112, BJ4201, BJ4202, BJ4203B, BJ4203D, BJ4207B, BJ4207D, BJ4202SAO, BJ4213A, BJ4213B BJ1103B8 (Jacob Chuck) Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Bộ dụng cụ sử dụng trong phẫu thuật xương QT 9 – phần II – Thông tư 39/2016/TT-BYT TTBYT Loại B
3 Hệ thống cưa xương (saw) System 4300/ BJ4301 System 1400/ BJ1401 System 1000/ BJ1101, BJ1108, BJ1106, BJ1109 System 4000/ BJ4101, BJ4108, BJ4106, BJ4109 System 6000/ BJ6101, BJ6200 System 5500/ BJ5501, BJ5501-II, BJ5506, BJ5509 System 8000/ BJ8101 Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Bộ dụng cụ sử dụng trong phẫu thuật xương QT 9 – phần II – Thông tư 39/2016/TT-BYT TTBYT Loại B
4 Hệ thống khoan xương (drill) System 5500/ BJ5503B/D/S, BJ5504, BJ5505, BJ5507B/D/S, BJ5507S System 4300/ BJ4307B System 1400/ BJ1402, BJ1403B, BJ1407B, System 1000/ BJ1102, BJ1102A, BJ1102SAO, BJ1103B/D, BJ1104, BJ1105, BJ1107B/D, BJ1103 System 4000/ BJ4102, BJ4102A, BJ4102SAO, BJ4103B/D, BJ4104, BJ4105, BJ4107B/D, BJ4103 System 6000/ BJ6107B, BJ6103B System 8000/ BJ8102, BJ8103, BJ8113 Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Bộ dụng cụ sử dụng trong phẫu thuật xương QT 9 – phần II – Thông tư 39/2016/TT-BYT TTBYT Loại B
5 Phụ kiện Pin (Battery) Cục sạc (Charger) Ổ sạc (Multi-charger) Hộp đựng pin (Battery case) Nắp đậy (Lid) Bộ chuyển đổi vô trùng (Aseptic transfer kit) Chìa khóa (Key) Nguồn điện (Power console) Dây nối (Connection wire) Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Bộ dụng cụ sử dụng trong phẫu thuật xương QT 9 – phần II – Thông tư 39/2016/TT-BYT TTBYT Loại B
6 Lưỡi cưa (Saw Blade) H/M/XA110221.37A/B/G; H/M/XA110221.27A/B/G; H/M/XA110221.2A/B/G; H/M/XA110221.0A/B/G; H/M/XA110220.9A/B/G; H/M/XA110220.8A/B/G; H/M/XA110220.7A/B/G; H/M/XA110181.37A/B/G; H/M/XA110181.27A/B/G; H/M/XA110181.2A/B/G; H/M/XA110181.0A/B/G; H/M/XA110180.9A/B/G; H/M/XA110180.8A/B/G; H/M/XA110180.7A/B/G; H/M/XA110141.37A/B/G; H/M/XA110141.27A/B/G; H/M/XA110141.2A/B/G; H/M/XA110141.0A/B/G; H/M/XA110140.9A/B/G; H/M/XA110140.8A/B/G; H/M/XA110140.7A/B/G; H/M/XA100221.37A/B/G; H/M/XA100221.27A/B/G; H/M/XA100221.2A/B/G; H/M/XA100221.0A/B/G; H/M/XA100220.9A/B/G; H/M/XA100220.8A/B/G; H/M/XA100220.7A/B/G; H/M/XA100181.37A/B/G; H/M/XA100181.27A/B/G; H/M/XA100181.2A/B/G; H/M/XA100181.0A/B/G; H/M/XA100180.9A/B/G; H/M/XA100180.8A/B/G; H/M/XA100180.7A/B/G; H/M/XA100141.37A/B/G; H/M/XA100141.27A/B/G; H/M/XA100141.2A/B/G; H/M/XA100141.0A/B/G; H/M/XA100140.9A/B/G; H/M/XA100140.8A/B/G; H/M/XA100140.7A/B/G; H/M/XA90221.37A/B/G; H/M/XA90221.27A/B/G; H/M/XA90221.2A/B/G; H/M/XA90221.0A/B/G; H/M/XA90220.9A/B/G; H/M/XA90220.8A/B/G; H/M/XA90220.7A/B/G; H/M/XA90181.37A/B/G; H/M/XA90181.27A/B/G; H/M/XA90181.2A/B/G; H/M/XA90181.0A/B/G; H/M/XA90180.9A/B/G; H/M/XA90180.8A/B/G; H/M/XA90180.7A/B/G; H/M/XA90141.37A/B/G; H/M/XA90141.27A/B/G; H/M/XA90141.2A/B/G; H/M/XA90141.0A/B/G; H/M/XA90140.9A/B/G; H/M/XA90140.8A/B/G; H/M/XA90140.7A/B/G; H/M/XA70221.37A/B/G; H/M/XA70221.27A/B/G; H/M/XA70221.2A/B/G; H/M/XA70221.0A/B/G; H/M/XA70220.9A/B/G; H/M/XA70220.8A/B/G; H/M/XA70220.7A/B/G; H/M/XA70181.37A/B/G; H/M/XA70181.27A/B/G; H/M/XA70181.2A/B/G; H/M/XA70181.0A/B/G; H/M/XA70180.9A/B/G; H/M/XA70180.8A/B/G; H/M/XA70180.7A/B/G; H/M/XA70141.37A/B/G; H/M/XA70141.27A/B/G; H/M/XA70141.2A/B/G; H/M/XA70141.0A/B/G; H/M/XA70140.9A/B/G; H/M/XA70140.8A/B/G; H/M/XA70140.7A/B/G. SW55160.7B; SW55160.5B; SW55160.3B; SW55140.7B; SW55140.5B; SW55140.3B; SW559.50.7B; SW559.50.5B; SW559.50.3B; SW50160.7B; SW50160.5B; SW50160.3B; SW50140.7B; SW50140.5B; SW50140.3B; SW509.50.7B; SW509.50.5B; SW509.50.3B; SW45160.7B; SW45160.5B; SW45160.3B; SW45140.7B; SW45140.5B; SW45140.3B; SW459.50.7B; SW459.50.5B; SW459.50.3B; SW35160.7B; SW35160.5B; SW35160.3B; SW35140.7B; SW35140.5B; SW35140.3B; SW359.50.7B; SW359.50.5B; SW359.50.3B. BJ3301-301503; BJ3301-301003; BJ3301-30803; BJ3301-181503; BJ3301-181003; BJ3301-18803. 2WF90131.0A/B; 2WF90130.8 A/B; 2WF9071.0 A/B; 2WF9070.8 A/B; 2WF70131.0 A/B; 2WF70130.8 A/B; 2WF7071.0 A/B; 2WF7070.8 A/B; 2WF50131.0 A/B; 2WF50130.8 A/B; 2WF5071.0 A/B; 2WF5070.8 A/B. WF90131.0 A/B; WF90130.8 A/B; WF90130.5 A/B; WF9071.0 A/B; WF9070.8 A/B; WF9070.5 A/B; WF9041.0; WF9040.8 A/B; WF9040.5 A/B; WF70131.0 A/B; WF70130.8 A/B; WF70130.5 A/B; WF7071.0 A/B; WF7070.8 A/B; WF7070.5 A/B; WF7041.0 A/B; WF7040.8 A/B; WF7040.5 A/B; WF50131.0 A/B; WF50130.8 A/B; WF50130.5 A/B; WF5071.0 A/B; WF5070.8 A/B; WF5070.5 A/B; WF5041.0 A/B; WF5040.8 A/B; WF5040.5 A/B; WF35131.0 A/B; WF35130.8 A/B; WF35130.5A/B; WF3571.0 A/B; WF3570.8 A/B; WF3570.5 A/B; WF3541.0 A/B; WF3540.8 A/B; WF3540.5 A/B; WF28131.0 A/B; WF28130.8 A/B; WF28130.5 A/B; WF2871.0 A/B; WF2870.8 A/B; WF2870.5 A/B; WF2841.0 A/B; WF2840.8 A/B; WF2840.5 A/B. SG/SSG640.8B; SG/SSG430.8B. SSG/SG940.8B; SSG/SG510.8B. BJF100251.37A/B/G; BJF100251.27A/B/G; BJF100251.2A/B/G; BJF100251.0A/B/G; BJF100131.37A/B/G; BJF100131.27A/B/G; BJF100131.2A/B/G; BJF100131.0A/B/G; BJF90251.37A/B/G; BJF90251.27A/B/G; BJF90251.2A/B/G; BJF90251.0A/B/G; BJF90131.37A/B/G; BJF90131.27A/B/G; BJF90131.2A/B/G; BJF90131.0A/B/G; BJF70251.37A/B/G; BJF70251.27A/B/G; BJF70251.2A/B/G; BJF70251.0A/B/G; BJF70131.37A/B/G; BJF70131.27A/B/G; BJF70131.2A/B/G; BJF70131.0A/B/G; BJF59251.37A/B/G; BJF59251.27A/B/G; BJF59251.2A/B/G; BJF59251.0A/B/G; BJF59131.37A/B/G; BJF59131.27A/B/G; BJF59131.2A/B/G; BJF59131.0A/B/G. BJ100241.2A; BJ100241.27A; BJ100251.2A; BJ100251.27A; BJ110241.2A; BJ110241.27A; BJ115221.2A; BJ115221.27A; BJ80140.8B; BJ80141.0A/B; BJ80141.2A/B; BJ80141.27A/B; BJ80141.0A/B; BJ80200.8B; BJ80201.0A/B; BJ80201.2A/B; BJ80201.27A/B; BJ80240.8B; BJ80241.0A/B; BJ80241.2A/B; BJ80241.27A/B; BJ80340.8B; BJ80341.0A/B; BJ80341.2A/B; BJ80341.27A/B; BJ70140.8B; BJ70141.0A/B; BJ70141.2A/B; BJ70141.27A/B; BJ70220.8B; BJ70221.0A/B; BJ70221.2A/B; BJ70221.27A/B; BJ70340.8B; BJ70341.0A/B; BJ70341.2A/B; BJ70341.27A/B; BJ50160.5B; BJ50160.8B; BJ50161.0A/B; BJ50200.5B; BJ50200.8B; BJ50201.0A/B; BJ55160.5B; BJ55160.8B; BJ55161.0A/B; BJ45100.5B; BJ45101.0A/B; BJ45140.5B; BJ45141.0A/B; BJ40140.5B; BJ40141.0A/B; BJ4080.8B; BJ359.50.5B; SW25100.5B; SW35100.5B; SW3580.6B; SW40140.6B; BJ3301-30150.3G; BJ3301-30100.3G; BJ3301-30080.3G; BJ3301-20150.3G; BJ3301-20100.3G; BJ2080.3G BF3570.8B; BF70130.9B; 2BF70131.0B; BF7070.8B; 2S75250.6B; 2S85250.9A/B/G; 2S90140.9A/B/G; 2S70250.9A/B/G; 2S85210.9A/B/G; 2S75251.27A/G; 2S80251.27A/G; 2S7018.50.8B; 2S100251.27A/G; 2S60190.6B; 2S75270.6B; 2S75130.6B; 2S90241.2A/G; 2S80131.2A/G; 2S70131.27A/G; 2S80131.27A/G; 2S85251.27A/G; 2S80191.27A/G; 2S8029W191.27A/G; 2S100191.27A/G; 2S9025W231.27F; 2S10025W231.27F; BJ3501-1590.4G; BJ3501-3012W90.4G; BJ3501-3512W90.4G; BJ3501-2590.4G; BJ3501-1570.4G; BJ3501-2570.4G; BJ3501-3090.4G; BJ3501-1560.4G; BJ3501-1570.5G; BJ3501-1590.5G; BJ3501-2590.5G; BJ3501-2570.5G; BJ3501-3090.5G; BJ3501-3012W90.5G; BJ3501-1560.5G; BJ3501-1060.4G; BJ3501-18.56.50.4G; 2S2590.6B; 2S3090.6B; 2BF70130.6B; BF7070.6B; BF9070.6B; BF80110.8B; BF3560.8B; 2S45400.7B; BF2R7.5-0.5B; SSG430.8B; H90120.9A/B/G; H90121.0A/B/G; H90121.2A/G; H90121.27A/G; H75190.9A/B/G; H90190.9A/B/G; H90191.2A/B/G; H90191.27A/B/G; H90191.37A/B/G; H7525W190.9A/B/G; H9025W190.9A/B/G; H9025W191.2A/B/G; H9025W191.27A/B/G; H10025W191.27A/B/G; H70340.8B; H80101.27A/G; H8025W191.27A/G; H90141.27A/G; JSOSW30140.4G; JSOSW285.50.4G; JSOSW30100.4G; JSOSW3560.4G; JSOSW3540.4G; JSOSW45140.4G; JSOSW45100.4G; JSOSW45200.4G; JSOSW2030.5B; 2HF70130.8B; HF90131.0B; EF33.59.40.6B; HF2R7.5-0.5B; SOF2R7.5-0.5B; JSO90130.9A/G; JSO90251.2A/G; JSO90251.27A/G; JSO90130.9F; JSO90131.0F; JSO90131.2F; JSO90131.27F; JSO90190.9F; JSO90191.0F; JSO90191.2F; JSO90191.27F; JSO70100.6B/G; JSO50100.4B/G; JSO70140.6B/G; JSO50140.4B/G; JSO90271.2A/G; JSO70271.0A/G; JSO2560.6B/G; JSO2560.4B/G; JSO25100.6B/G; JSO25100.4B/G; JSO25140.6B/G; JSO25140.4B/G SSW1560.4G; SSW2580.4G; SSW3060.4G; SSW20100.4G; SSW3060.6B/G; SSW30100.4G; SSW25120.4G; SF80101.0B; 2SF70121.0B; 2SF70121.2A; SF2R7.5-0.5B; DE90250.8B/G; DE85251.2A/G; DE70250.8B/G; DE60130.6B/G; DE85190.8B/G; DE8532W251.2A/G; DE90250.8B/G; DE90251.2A/G; DE65330.8B/G; DE85130.8B/G; DE85131.2A/G; ESG640.5B XA70121.0A/B/G; XA70121.2A/G; XA70121.27A/G; XA90181.0A/B/G; XA90181.2A/G; XA90181.27A/G; XA100221.0A/B/G; XA100221.2A/G; XA100221.27A/G; M100191.27G; M9022W131.37G; M7525W230.9F; M9025W230.9F; M9025W231.0F; M9025W231.2F; M9025W231.27F; M9018W160.9F; M9018W161.27F; M9018W161.37F; M10018W161.27F; M85101.27A; M90250.9G; M90251.0G; M90251.2G; M90251.27G; M90251.37G; M90190.9A; M90191.0A; M90191.2A; M90191.27A; M90191.37A; M90120.9G; M90121.0G; M90121.2G; M90121.27G; M90121.37G; M35530.4G; M50420.6G; M30830.6G; TPLO blade (L=25-55, d=R10-R33); TPLO(R=12-30) Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Bộ dụng cụ sử dụng trong phẫu thuật xương QT 9 – phần II – Thông tư 39/2016/TT-BYT TTBYT Loại B
7 Mũi khoan (Drill bit) BJP007; BJ11021; BJ41021SAO; BJ32011; BJ32012; BJ340210-1-4; BJ340210-1-5; BJ340210-1-6; BJ340210-1-8; BJ340210-1-10; BJ340210-1-12; BJ340210-1-14; BJ340210-1.1-4; BJ340210-1.1-5; BJ340210-1.1-6; BJ340210-1.1-8; BJ340210-1.1-10; BJ340210-1.1-12; BJ340210-1.1-14; BJ340210-1.5-4; BJ340210-1.5-5; BJ340210-1.5-6; BJ340210-1.5-8; BJ340210-1.5-10; BJ340210-1.5-12; BJ340210-1.5-14; BJ340210-1.8-4; BJ340210-1.8-5; BJ340210-1.8-6; BJ340210-1.8-8; BJ340210-1.8-10; BJ340210-1.8-12; BJ340210-1.8-14; BJ11021; BJ41021SAO. Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Bộ dụng cụ sử dụng trong phẫu thuật xương QT 9 – phần II – Thông tư 39/2016/TT-BYT TTBYT Loại B
8 Doa ổ cối (Acetabulum reamer) và cán doa (Reamer shaft) BJ1107B1; BJ1107B1T; BJ1107B1/D1; BJ1107B2; BJ1107D2; BJ1107S1T; BJ1107D1T; BJ1107B1L/D1L; BJ1107-2; BJ1107B2T; BJ1107S2T; BJ1107D2T Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Shanghai Bojin Electric Instrument & Device Co., Ltd / Trung Quốc Bộ dụng cụ sử dụng trong phẫu thuật xương QT 9 – phần II – Thông tư 39/2016/TT-BYT TTBYT Loại B