STT Tên trang 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 Dụng cụ đánh bóng răng giả ExaCerapol (0301UM-12, 0302UM-12, 0315UM-12, 0310UM-12, 0311UM-12, 0330HP-12, 0351HP-12, 0384HP-12, 0301UM-100, 0302UM-100, 0315UM-100, 0310UM-100, 0311UM-100, 0330HP-100, 0351HP-100, 0384HP-100, 0306UM-12, 0307UM-12, 0320UM-12, 0316UM-12, 0317UM-12, 0340HP-12, 0361HP-12, 0394HP-12, 0306UM-100, 0307UM-100, 0320UM-100, 0316UM-100, 0317UM-100, 0340HP-100, 0361HP-100, 0394HP-100). Cerapol Super (0321UM-12, 0322UM-12, 0371HP-12, 0373HP-12, 0375HP-12, 0374HP-12, 0321UM-100, 0322UM-100, 0371HP-100, 0373HP-100, 0375HP-100, 0374HP-100). CeraPro (8001.050HP, G8001.050HP, 8002.040HP, G8002.040HP, 8003.150HP, 8004.120HP, 8005.035HP, 8006.050HP, 8007.040HP). CeraTec (952.040HP, 955.035HP, 956.050HP, 957.040HP, 958.035HP, 959.040HP). CeraGloss (341HP, 342HP, 343HP, 344HP, 301HP, 310HP, 3041HP, 3042HP, 3043HP, 3044HP, 3001HP, 3010HP, 3047HP, 30041HP, 30042HP, 30043HP, 30044HP, 30001HP, 30010HP, 30047HP, 2532HP, 2934HP). StarGloss (R1020HP, R2020HP, R1520HP, R1030HP, R2030HP, R1530HP, R1040HP, R2040HP, R5410HP). StarTec (ST1020HP, ST1030HP, ST1040HP, ST2030HP, ST1530HP, ST2040HP, ST1540HP ). CeraStar (901.050HP, 902.040HP). Alphaflex(0001UM-12, 0005UM-12, 0023UM-12, 0101UM-12, 0105UM-12, 0123UM-12, 0001UM-100, 0005UM-100, 0023UM-100, 0101UM-100, 0105UM-100, 0123UM-100, 0040HP-12, 0041HP-12, 0042HP-12, 0043HP-12, 0044HP-12, 0045HP-12, 0046HP-12, 0047HP-6, 0040HP-100, 0041HP-100, 0042HP-100, 0043HP-100, 0044HP-100, 0045HP-100, 0046HP-100, 0047HP-100, 0140HP-12, 0141HP-12, 0142HP-12, 0143HP-12, 0144HP-12, 0145HP-12, 0146HP-12, 0147HP-6, 0140HP-100, 0141HP-100, 0142HP-100, 0143HP-100, 0144HP-100, 0145HP-100, 0146HP-100, 0147HP-100, BRY0141HP-12, BRY0142HP-12, BRY-0143HP-12, BRY0141HP-100, BRY0142HP-100, BRY-0143HP-100). Goldstar (1801UM-12, 1802UM-12, 1803UM-12, 18044HP-12, 1801UM-100, 1802UM-100, 1803UM-100, 18044HP-100, 1811UM-12, 1812UM-12, 1813UM-12, 18144HP-12, 1811UM-100, 1812UM-100, 1813UM-100, 18144HP-100, 1821UM-12, 1822UM-12, 1832UM-12, 18244HP-12, 1821UM-100, 1822UM-100, 1832UM-100, 18244HP-100 ). Exa Technique (BR01UM-12, BR01UM-100, BR02UM-12, BR02UM-100, BR03UM-12, BR03UM-100). Blue Line (Blau 0401UM-12, Blau 0401UM-100, Blau 0402UM-12, Blau 0402UM-100, Blau 0410UM-12, Blau 0410UM-100, Blau 0411UM-12, Blau 0411UM-100, Blau 0440HP-12, Blau 0440HP-100, Blau 0442HP-12, Blau 0440HP-100). Diamond Finishing strip ( DS6, FDS6, CDS6 ) Edenta Etablissement Edenta Etablissement- Liechtenstein / Edenta AG - Switzerland Sử dụng trong quá trình sửa soạn, hoàn tất các mẫu hàm răng giả 4 TTBYT Loại A
2 Dụng cụ cắt sáp Wax trimmer (266.103.023HP, 266R.103.023HP, 354R.103.015HP, 354R.103.023HP). Wax cutter (3680.103.010HP, 3680.103.015HP, 3680.103.023HP, 3680.123.010HP, 3680.123.015HP, 3780.103.023HP, 3780.103.031HP, 3780.103.040HP, 3780.123.023HP, 3781.103.023HP, 3781.103.031HP, 3781.103.040HP, 3781.123.031HP, 3781.123.040HP) Edenta Etablissement Edenta Etablissement- Liechtenstein / Edenta AG - Switzerland Sử dụng trong quá trình sửa soạn, hoàn tất các mẫu hàm răng giả 4 TTBYT Loại A
3 Dụng cụ hoàn tất Shoulder Cutter (4060.103.027HP, 4060.103.029HP, 4060.103.032HP), Milling Set (900.600SO-2.35mm, 900.610SO-3.00mm), Hollow Grinder (490.104.090HP, 490.104.110HP ), MT Milling Diamonds (356.316.023FG, F356.316.023FG, C356.316.023FG, UF356.316.023FG, 364.316.010, F364.316.010FG, C364.316.010FG, UF364.316.010FG). Edenta Etablissement- Liechtenstein Edenta Etablissement- Liechtenstein / Edenta AG - Switzerland Sử dụng trong quá trình sửa soạn, hoàn tất các mẫu hàm răng giả 4 TTBYT Loại A
4 Dụng cụ cắm mũi khoan Bur Blocks (40500.00, 40510.00, 40530.00, 40570.00, 40580.00, 40600, 40601, 40602, 40603, 40610 ) Edenta Etablissement- Liechtenstein Edenta Etablissement- Liechtenstein / Edenta AG - Switzerland Sử dụng trong quá trình sửa soạn, hoàn tất các mẫu hàm răng giả 4 TTBYT Loại A
5 Đĩa cắt răng giả Diamond Disc ( 327.514.080, 327.514.100, 366.504.220HP, 367.504.220HP, 317.514.220HP, 317.514.220HP, 350.514.190HP, 350.524,190HP, 350.514.220HP, 350.524.220HP, 351.514.220HP, 351.524.220HP, 353.504.220HP, 353.514.220HP, 353.524.220HP, 355.504.190HP, 355.504.220HP, 355.514.1160HP, 355.514.190HP, 355.514.220HP, 355.524.190HP, 355.524.220HP, 356.514.190HP, 356.514.220HP, 357.514.190HP, 357.514.220HP, 358.514.190HP, 358.524.190HP, 358.514.220HP, 358.524.220HP, 361.514.080HP, 361.514.100HP, 363.514.100HP, 393.514.220HP, 396.514.220HP, 400.514.220HP, 400.514.190HP, 405.514.220HP, 405.524.220HP, 605.514.220HP, 605.524.220HP, 705.514.190HP, 705.514.220HP, 321.514.190HP, 321.524.190HP, 321.514.220HP, 321.524.220HP, 335.524.220HP, 345.514.190HP, 345.514.220HP, 345.524.220HP, 365.524.300HP, 365.524.450HP, 378.524.450HP, 505.504.160HP, 505.504.190HP, 505.504.220HP, 505.514.190HP, 505.514.220HP, 362.524.100HP, 362.524.100HP, 354.524.220HP ) Edenta Etablissement- Liechtenstein Edenta Etablissement- Liechtenstein / Edenta AG - Switzerland Sử dụng trong quá trình sửa soạn, hoàn tất các mẫu hàm răng giả 4 TTBYT Loại A
6 Mũi cắt răng giả TC Cutter ( 0110.023HP, 0210.023HP, 0310.023HP, 0410.023HP, 0610.023HP, 0710.023HP, 0810.023HP, 0910.016HP, 0910.023HP, 1010.023HP, 1110.023HP, 1210.016HP, 1310.008HP, 1310.009HP, 1310.010HP, 1510.014HP, 1610.014HP, 1710.023HP, 1810.023HP, 3510.012HP, 5110.006HP, 5210.060HP, 5310.060HP, 5410.060HP, 5510.060HP, 5610.045HP, 5710.040HP, 5810.060HP, 5910.060HP, 6110.040HP, 6210.040HP, 6310.060HP, 6410.031HP, 65110.060HP, 7010.060HP, 7110.010HP, 7110.012HP, 7110.014HP, 7110.016HP, 7110.018HP, 7110.023HP, 7110.025HP, 7110.027HP, 7110.029HP, 7110.031HP, 7110.035HP, 7110.040HP, 7110.050HP, 7110.060HP, 7110.080HP, 7210.040HP, 7210.060HP, 7710.023HP, 7710.029HP, 0120.023HP, 0220.023HP, 0320.023HP, 0420.010HP, 0420.012HP, 0420.023HP, 0620.023HP, 0720.023HP, 0820.023HP, 0920.023HP, 1220.016HP, 1520.014HP, 1620.014HP, 1720.023HP, 1820.023HP, 3520.012HP, 5120.060HP, 5220.060HP, 5320.060HP, 5420.060HP, 5520.060HP, 5620.045HP, 5720.040HP, 5820.060HP, 6120.040HP, 6220.040HP, 6320.060HP, 6420.031HP, 7020.060HP, 7120.023HP, 7220.060HP, 7720.014HP, 7720.023HP, 7720.029HP, 0124.023HP, 1124.023HP, 1924.023HP, 2024.023HP, 2124.023HP, 2224.023HP, 5424.060HP, 6924.040HP, 7224.040HP, 1324.008HP, 1324.009HP, 1324.010HP, 0725.023HP, 0825.023HP, 1225.016HP, 1325.008HP, 1425.014HP, 1725.023HP, 6925.040HP, 7225.060HP, 0726.023HP, 0826.023HP, 1226.016HP, 1726.023HP, 6926.040HP, 0727.023HP, 0827.023HP, 1727.023HP, 6927.040HP, 7227.040HP, 7227.060HP, 0130.023HP, 0230.023HP, 0430.023HP, 0630.023HP, 0730.023HP, 0830.023HP, 0930.023HP, 1030.023HP, 1130.023HP, 1230.016HP, 1430.014HP, 1730.023HP, 1830.023HP, 5630.045HP, 5730.040HP, 5730.045HP, 7230.023HP, 7230.040HP, 7730.014HP, 7730.023HP, 7730.029HP, 0131.023HP, 0231.023HP, 0431.023HP, 0931.023HP, 1131.023HP, 0140.023HP, 0240.023HP, 0440.023HP, 0840.023HP, 5740.045HP, 0441.023HP, 1741.023HP, 5741.045HP, 5150.060HP, 5250.060HP, 5350.060HP, 5450.060HP, 5550.060HP, 5650.045HP, 5850.060HP, 6055.070HP,0160.023HP, 0260.023HP, 0460.023HP, 1360.009HP, 1360.010HP, 1460.016HP, 5760.045HP, 5453.060HP, 6953.040HP, 7053.060HP, 1370.008HP, 1370.009HP, 1370.010HP, 5170.060HP, 5270.060HP, 5370.060HP, 5470.060HP, 5570.060HP, 5670.045HP, 5770.040HP, 5870.060HP, 5970.060HP, 6370.060HP, 6470.031HP, 6570.060HP, 7070.060HP, 7170.027HP, 7170.031HP, 7170.040HP, 7170.050HP, 7170.060HP, 7270.040HP, 7270.060HP, 0175.023HP, 5275.060HP, 5775.045HP, 6075.070HP, 7275.060HP, 7775.040HP, 5180.060HP, 5280.060HP, 5380.060HP, 5480.060HP, 5580.060HP, 5680.045HP, 5880.060HP, 5485.060HP, 5885.060HP, 6085.070HP, 5490.060HP, L0420.023HP, L5620.045HP, L0110.023HP, L5610.045HP, L5410.060HP, L6055.070HP, 513.014HP, 515.023HP, C514.023HP, C515.023HP, C108.104.060 ).TC Cutter VOLCANO ( DLC-0110.023HP, DLC-0210.023HP, DLC-0410.023HP, DLC-0610.023HP, DLC-1110.023HP, DLC-1210.016HP, DLC-1310.010HP, DLC-1610.014HP, DLC-5610.045HP, DLC-5710.040HP, DLC-5510.060HP, DLC-5210.060HP, DLC-5310.060HP, DLC-5410.040HP, DLC-7210.060HP, DLC-0120.023HP, DLC-0220.023HP, DLC-0420.023HP, DLC-1220.016HP, DLC-1620.014HP, DLC-5620.045HP, DLC-5720.040HP, DLC-5420.060HP, DLC-7220.060HP, DLC-1324.010HP, DLC-5424.060HP, DLC-6924.040HP, DLC-5450.060HP, DLC-5650.045HP ). CAD/CAM Cutter ( 202D.6.15.010, 202DA.6.15.010, 202D.6.20.020, 202DA.6.20.020, 202D.3.15.010, 202D.3.20.020, 202DR.3.16.010, 202DR.3.20.020, 202DR.3.20.025, 202.6.12.010, 202R.3.06.006, 202R.3.07.007, 202R.3.12.007, 202R.3.16.010, 202R.3.20.020, 202R.3.20.025, 202C.3.15.010, 202C.3.20.020, 201.6.15.010, 201.3.12.010, 201.3.12.020, 201.3.16.010, 201.3.20.020, 201A.6.15.010, 201R.3.16.010, 201R.3.16.020, 102.3.15.010, 202B.6.15.010, 202BA.6.15.010, 202B.6.20.020, 202B.3.15.010, 202BR.3.16.010, 203BR.3.16.020, 202R.3S.07.007, 202R.3S.16.010, 202R.3S.20.025, 202R.3.15.010, 202R.3.05.006, 202R.3.16.006, 203R.3.16.020, 203R.3.16.030, 202.6.15.010, 202A.6.15.010, 202.6.20.020, 202.3.10.010, 202.3.14.010, 202.3.15.013, 202.3.15.015, 202.3.15.020, 202.3.08.007, 202.3.10.007, 202.3.18.010, 202.3.20.010, 202.3.20.020, 202R.3.02.006, 202R.3.08.010, 202R.3.12.020 ) Edenta Etablissement- Liechtenstein Edenta Etablissement- Liechtenstein/ Edenta AG - Switzerland Sử dụng trong quá trình sửa soạn, hoàn tất các mẫu hàm răng giả 4 TTBYT Loại A