| 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 |
AFFINITY CCTM Cobalt Chromium Sirolimus-Eluting Stent |
25600CC, 25601CC, 25602CC, 25603CC, 25604CC, 25605CC, 25606CC, 25607CC, 25608CC, 25627CC, 25628CC, 25629CC, 25630CC, 25610CC, 25819CC, 25611CC, 25612CC, 25613CC, 25614CC, 25616CC, 25630CC, 25631CC, 25632CC, 25633CC, 25634CC, 25635CC, 25636CC, 25637CC, 25638CC, 25639CC, 25640CC, 25641CC, 25642CC, 25643CC, 25644CC, 25645CC, 25646CC, 25647CC, 25648CC, 25649CC, 25400CC, 25401CC, 25403CC, 25404SS, 25408CC, 25406CC, 25407CC, 25408CC, 25409CC, 25410CC, 25500CC, 25501CC, 25502CC, 25503CC, 25504CC, 25505CC, 25506CC, 25507CC, 25508CC, 25509CC, 25510CC, 25511CC, 25512CC, 25513CC, 25514CC, 25515CC, 25516CC, 25517CC, 25518CC, 25519CC, 25520CC, 25521CC, 25559CC, 25650CC, 25561CC, 25652CC, 25653CC,25654CC, 25655CC, 25656CC, 25657CC ,25658CC, 25659CC, 25660CC, 25670CC, 25671CC, 25677CC, 25700CC, 2570CC, 2570288, 25703CC, 25704CC, 25705CC, 25706CC, 25707CC, 25708CC, 25709CC, 25710CC, 25711CC, 2572SS, 25713CC, 25714CC, 25715CC, 25716CC, 25717CC, 25718CC, 25719CC, 25720CC, 25721CC, 25800SS, 25801CC, 25802CC, 25803CC, 25804CC, 25805CC, 25806CC, 25807CC, 25808CC, 25809CC, 25810CC, 25811CC, 25812CC, 25813CC, 25814CC, 25815CC, 25816CC, 25817CC, 25818CC, 25820CC, 25821CC, 25900CC, 25901CC, 25902CC, 25903CC, 25904CC, 25905CC, 25906CC, 25907CC, 25909CC, 25910CC, 25911CC ,25912CC ,25913CC , 25914CC, 25915CC, 25916CC, 25917CC, 25918CC, 25919CC, 25920CC, 25921CC, 25618CC, 25619CC, 25620CC, 25621CC, 25622CC, 25623CC, 25624CC, 25908CC
|
Umbra Medical Products
|
Umbra Medical Products |
Khung giá đỡ mạch vành |
Quy tắc 8, Phần II, Phụ lục 1, TT 39/2016/TT-BYT |
TTBYT Loại D |
| 2 |
HAWKTM HP/NC PTCA Balloon Dilatation Catheter Non-Compliant |
NC79120, NC79124, NC79125, NC79126, NC79121, NC79122, NC79217, NC79123, NC79128, NC79129, NC79130, NC79016, NC71101, NC79017, NC78912, NC79131, NC79103, NC78915, NC79020, NC71105, NC79132, NC79025, NC76212, NC79026, NC77061, NC79133, NC79028, NC79029, NC79031, NC79034, NC78911, NC79035, NC79134, NC78918, NC79039, NC78918, NC79135, NC79136, NC79137, NC79138, NC79139, NC79140, NC79046, NC75801, NC79047, NC79141, NC75803, NC79051, NC75805, NC759142, NC79143, NC79144, NC79145, NC79146, NC79147, NC77601, NC77610, NC77603, NC77694, NC77605, NC77620, NC79148, NC79149, NC79150, NC71103, NC79152, NC76210, NC79153, NC79154, NC76214, NC79155, NC79151
|
Umbra Medical Products
|
Umbra Medical Products |
Bóng nong mạch vành |
Quy tắc 8, Phần II, Phụ lục 1, TT 39/2016/TT-BYT |
TTBYT Loại D |
| 3 |
Glidestat Hydrophilic Guide Wire |
19267-H, 19260-H, 19311-H, 19242-H, 19235-H, 19310-H, 19320-H, 19318-H, 19161-H, 19166-H, 19238-H, 19262-H, 19315-H, 19243-H, 10238-H, 19314-H, 19329-H, 19265-H, 19319-H, 19268-H, 19240-H, 19260-H, 19265-H, 19268-H, 19309-H, 19311-H, 19314-H, 19315-H, 19318-H, 19340-H, 19319-H, 19328-H, 19337-H, 19508-H, 19452-H, 19543-H, 19290-H, 19295-H, 19291-H, 19292-H, 19293-H, 19294-H, 19300-H, 19304-H, 19306-H, 19307-H, 19328-H, 19341-H, 19500-H, 19502-H, 19296-H 19503-H, 19504-H, 19506-H, 19508-H, 19509-H, 19297-H , 19510-H, 19522-H, 19523-H, 19526-H, 19527-H, 19550-H, 19298-H, 19551-H, 19299-H 19552-H, 19553-H, 19554-H, 19555-H, 19556-H, 19557-H, 19558-H, 19559-H, 19560-H, 19561-H
|
Umbra Medical Products
|
Umbra Medical Products |
Dây dẫn can thiệp |
Quy tắc 7, Phần II, Phụ lục 1, TT 39/2016/TT-BYT |
TTBYT Loại C |
| 4 |
Clearview |
14237
|
Umbra Medical Products
|
Umbra Medical Products |
Khóa 3 ngã áp lực cao |
Quy tắc 11, Phần II, Phụ lục 1, TT 39/2016/TT-BYT |
TTBYT Loại C |
| 5 |
Advance Diagnostic Guide Wire |
19267, 19260, 19311, 19242, 19235, 19310, 19320, 19318, 19161, 19166, 19238,19262, 19315, 19243, 10238, 19314, 19329, 19265, 19319, 19268, 19240, 19260, 19265, 19268, 19309, 19311, 19314, 19315, 19315-P, 19318, 19319, 19238, 19337, 19452, 19453, 19166, 19161, 19262-D, 19328, 19503, 19542, 19543
|
Umbra Medical Products
|
Umbra Medical Products |
Dây dẫn chẩn đoán can thiệp |
Quy tắc 7, Phần II, Phụ lục 1, TT 39/2016/TT-BYT |
TTBYT Loại C |
|
