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