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 RADIALSTATTM Transradial Sheath Kit 06220, 06221, 06222, 06223, 06660, 06661, 06662, 06663, 06664, 06665, 06666, 06667, 06668, 09209, 09210, 09212, 09215, 09215-1, 09216, 09216-1, 0666HC, 06667HC, 09217, 09217-1, 09210HC, 09212, 09212-1, 06666HC, 09212-S21, 09212-S25, 09212HC, 09215, 09215-1, 09216, 06664HC, 09216-1, 09213, 09217, 09217-1, 09218-1, 09218, 09208, 09209, 09210, 09211, 09212, 06663HC, 09040, 09041, 09042, 09043, 099908, 099918, 09991MM, 09219-1, 09219, 09219HC, 09213 Umbra Medical Products Umbra Medical Products Dụng cụ mở đường vào mạch máu Quy tắc 7, Phần II, Phụ lục 1, TT 39/2016/TT-BYT TTBYT Loại C
2 AFFINITY NP TM Polymer-free Sirolimus Eluting Coronary stent System 25401-NP, 25402-NP, 25411-NP, 25403-NP, 25404-NP, 25405-NP, 25407-NP, 25409-NP, 25410-NP, 25603-NP, 25605-NP, 25606-NP, 25607-NP, 25608-NP, 25611-NP, 25614-NP, 25618- NP, 25620- NP, 25621- NP, 25703-NP, 25705- NP, 25707- NP, 25708- NP, 25711-NP, 25714- NP, 25718- NP, 25720- NP, 25721-NP, 25801- NP, 25803- NP, 25805-NP, 25807- NP, 25808- NP, 25521- NP, 25811-NP, 25814- NP, 25818- NP, 25820- NP, 25821- NP, 25903-NP, 25905- NP, 25907- NP, 25908- NP, 25911-NP, 25914- NP, 25918- NP, 25920- NP, 25921-NP, 25503- NP, 25505- NP, 25507- NP, 25508-NP, 25514- NP, 25518- NP, 25511- NP, 15085-NP, 15086- NP, 15087- NP, 15088- NP, 15089-NP, 15230- NP, 15231- NP, 15232- NP, 15233-NP, 15234- NP, 15510- NP, 15511- NP, 15512-NP, 15513- NP, 15514- NP, 15231- NP, 15232-NP, 15233- NP, 15234- NP, 15510- NP, 15511-NP, 15512- NP, 15513- NP, 15514- NP, 15515-NP, 15516- NP, 15517- NP, 15518- NP, 15519-NP, 15520- NP, 15521- NP, 15522- NP, 15523-NP, 15524- NP, 15525- NP, 15526- NP, 15527-NP, 15528- NP, 15529- NP, 15530- NP, 15531-NP, 15532- NP, 15533- NP, 15534- NP, 15535-NP, 15536- NP, 15537- NP, 15538- NP, 15539-NP, 15540- NP, 15541- NP, 15542- NP, 15543- NP 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
3 HAWKTM PTCA Balloon Dilatation Catheter 70000, 70001, 70002, 70003, 70004, 70005, 70006, 70007, 70008, 70009, 70010, 70011, 70012, 70013, 70014, 70015, 70016, 70017, 70020, 73501, 73508, 73509, 73510, 73511, 73503, 73512, 73513, 73505, 71113, 71101, 71114, 71108, 71109, 71103, 71117, 71118, 71105, 76224, 76212, 76225, 76226, 76220, 76214, 76228, 76230, 76231, 76232, 76233, 73230, 78921, 78911, 78941, 78920, 78922, 78918, 78942, 78943, 78915, 75806, 75801, 75807, 75808, 75811, 75803, 75809, 75810, 75805, 77609, 77610, 77611, 77612, 77613, 77604, 77614, 77615, 77606, 78921, 78911, 78941, 78920, 78922, 78918, 78942, 78943, 78915, 75806, 75801, 75807, 75808, 75811, 75803, 75809, 75810, 75805, 77609, 77610, 77611, 77612, 77613, 77604, 77606, 77614, 77615, 77620, 72001, 72002, 72003, 72004, 72005, 72006, 72007, 72008, 72010, 72500, 72501; 72502, 72503, 72504, 72505, 74601, 74602, 74603, 74604, 74605, 74606, 74607, 74608, 74609 74610, 79106, 79013, 79107, 79123, 79108, 79100, 79122, 79014, 79101, 79102, 79109, 79103, 79110, 79015, 79016, 71101, 79017, 79018, 79019, 71130, 79020, 79021, 79022, 79023, 79104, 79024, 79000, 79001, 79002, 79003, 79004, 79005, 79101, 79103, 79104, 79006, 79007, 79008, 79102, 79105, 73500, 73501, 79010, 79121, 73503, 79011, 73505, 79012, 79113, 79114, 79115, 79116, 79117, 79118, 79046, 79047, 79048, 79049, 79050, 79051, 79052, 79053, 79054, 79055, 79056, 79119, 79057, 79058, 79059, 79060, 79601, 79112, 79025, 79026, 79027, 79028, 79029, 79030, 79031, 79032, 79033, 79111, 79034, 79035, 79036, 79037, 79038, 79039, 79040, 79041, 79042, 79043, 79044, 79045, 15095, 15096, 15097, 15098, 15099, 78999, 79061, 78998, 78997, 78996, 78995, 79024, 15220, 15221, 15222, 15223, 15224, 15435, 15436, 15437, 15438, 15439, 79200, 79201, 79202, 79203, 79204, 79205, 79206, 79207, 79208, 79209, 79210, 79212, 79213, 79214, 79215, 79216, 79217, 79218, 79219, 79220, 79221, 79222, 79223, 79224, 79225, 79226, 79227, 79228, 79229, 79230, 79231, 79232, 79233, 79234, 79235, 79236, 79237, 79238, 79239, 79240, 79241, 79242, 79243, 79244, 79245, 79246, 79247, 79248, 79249, 79250, 79251, 79252, 79253, 79254, 79255, 79256, 79257, 79258, 79259, 73502, 79400, 79401, 79402, 79403, 79404, 79405, 79406, 79407, 79408, 79409, 79410, 79411, 79412, 79413, 79414, 79415, 79416, 79417, 79418, 79419, 79420, 79421, 79422, 79423, 79424, 79425, 79426, 79427, 79428, 79429, 79430, 79431, 79432, 79433, 79434, 79435, 79436, 79437, 79438, 79439, 79440, 79441, 79442, 79443, 79444, 79445, 79446, 79447, 79448, 79449, 79450, 79451, 79452, 79453, 79454, 79455, 79456, 79457, 79458, 79459, 79460, 79461, 79462, 79463, 79464, 79465, 79466, 79467, 79468, 79469, 79470, 79471, 79472, 79473, 79474, 79475, 79476, 79477, 79478, 79479, 79480, 79481, 79482, 79483, 79484, 79485, 79486, 79487, 79488, 79489, 79490, 79491, 79492, 79493, 79494, 79495, 79496, 79497, 79498, 79499, 79600, 79601, 79602, 79603, 79604, 79605, 79606, 79607, 79608, 79609, 79610, 79611, 79612, 79613, 79614, 79615, 79616, 79617, 79618, 79619, 79620, 79621, 79622, 79623, 79624, 79625, 79626, 79627, 79628, 79629, 79630, 79631, 79632, 79633, 79634, 79635, 79636, 79637, 79638, 79639, 79640, 79641, 79642, 79643, 79644, 79645, 79646, 79647, 79648, 79649, 79650, 79651, 79652, 79653, 79654, 79655, 79656, 79657, 79658, 79659, 79660, 79661, 79662, 79663, 79664, 79665, 79666, 79667, 79668, 79669, 79670, 79671, 79672, 79673, 79674, 79675, 79676, 79677, 79678, 79679, 79680, 79681, 79682, 79683, 79684, 79685, 79686, 79687, 79688, 79689, 79690, 79691, 79692, 79693, 79694, 79695, 79696, 79697, 79698, 79699, 79700, 79701, 79702, 79703, 79704, 79705, 79706, 79707, 79708, 79709 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
4 FALCONTM Guiding Catheters 7781-10, 7781-20, 7781-A0,7834-A0, 7805-10, 7806-10, 7859-30, 7859-60, 7859-C0, 7834-10, 7805-40,7806-40, 7859-CO,7859-40,7859-AO, 7834-30, 7846-10, 7846-20, 7846-40, 7846-30, 7844-40,7824-AO,7833-80, 7875-10, 7775-20, 7875-30, 7733-JO, 7874-10, 7874-20,7874-30, 7874-40, 7877-10, 7877-20, 7876-10, 7876-20, 7833-HO,7838-50,7838-EO,7870-10, 7838-60, 7838- FO, 7838-70, 7838- GO, 7838- 8O, 7821- AO, 7821- 8O, 7821- JO,7824 -10, 7820-AO, 7820- 80, 7820- JO, 7820- CO, 7819-50, 7819-60, 7814-40, 7814-50, 7823-20, 7833- 50, 7833- EO, 7833- 60, 7463- 20, 7832-LO, 7831- A0, 7833- 50, 7833- EO, 7833- 60, 7833- FO, 7831- 80, 7831- CO, 7844-60, 7844-10, 7844-20, 7844-30, 7844-40, 7838- 10, 7838- 20, 7832- 10, 7832- 20, 7838- H0, 7876- 10, 7876- 50, 7876- 20, 7876-60, 7876-30, 7876-70, 7876-40 Umbra Medical Products Umbra Medical Products Ống thông trợ giúp can thiệp Quy tắc 7, Phần II, Phụ lục 1, TT 39/2016/TT-BYT TTBYT Loại C
5 OSPREYTM Diagnostic Angiographic Catheters 7704-30,7529-33,7509-33, 7704-10, 7776-21, 7509-11,7707-10, 7600-11, 5577-23, 5577-83, 7572-11,7705-20, 7530-23, 7722-CO, 7722-30, 5577-C3, 5577-33, 7722-00, 7722-10, 7722-80, 7722-40, 5577-03, 5577-43,7722-EO, 7722-50, 5577-B3, 5577-53, 5565-13,5577-13, 5577-A3, 5408-13, 5565-23, 5408-23, 7751-02, 7560-23, 7560-33,7751-30, 7560-63,7722-10, 7722-AO, 7660-33,7751-10, 7560-13, 7660-AO, 7703-10, 7527-13, 7507-13, 7703-83, 8823-23, 8822-33, 7527-33, 7507-23, 7703-30,7527-33, 7507-33, 7702-10, 7528-13, 7508-13, 8822-23,7746-CO, 7720-20, 7528-23, 7702-40, 7526-11, 7506-11, 5565-33, 5408-33, 5565-L3, 7709-10,5594-13, 7534-13, 7510-13, 7709-20, 7534-23, 7510-23, 5565-43, 5408-43, 5365-53, 5408-53,7719-AO, 7706-10, 7531-13, 7511-13, 7602-42,7608-51, 7602-61, 7413-21, 7602-71, 7602-81, 7746-20, 7501-H1, 7700-30, 7501-53, 7501-33,7700-40, 7521-43, 7501-83, 7602-91, 7712-A07746-3O, 7712-10, 7701-10, 7523-13, 7503-13,7701-20, 7523-21, 7503-21, 5586-A3, 5586-13,4476-10, 7712-30,7701-30, 7523-33, 7703-33, 7501-40, 7523-83, 7503-83, 7708-10, 7523-13,7746-AO, 7513-A3, 7708-20,7623-33, 7513-23, 7708-50, 7710-00, 5584-03, 7745-10, 5563-P3,5573-33, 5412-23, 5590-A3,7715-A0, 5575-A3,5590-13, 7715-8O, 5575-83,5590-23, 5590-33, 5573-23, 7745-80, 7745-A0, 713-A0, 5587-A3, 7745-60, 7745-J0, 5564-K3, 5564-63, 5573-03,5564-L3, 5564-73, 5573-A3, 5564-M3, 5564-33,5573-13 Umbra Medical Products Umbra Medical Products Ống thông chẩn đoán can thiệp Quy tắc 11, Phần II, Phụ lục 1, TT 39/2016/TT-BYT TTBYT Loại C
6 RADIALSTATTM Transradial Sheath Kit 06220, 06221, 06222, 06223, 06660, 06661, 06662, 06663, 06664, 06665, 06666, 06667, 06668, 09209, 09210, 09212, 09215, 09215-1, 09216, 09216-1, 0666HC, 06667HC, 09217, 09217-1, 09210HC, 09212, 09212-1, 09212-S21, 09212-S25, 09212HC, 09215, 09215-1, 09216, 06664HC, 09216-1, 09213, 09217, 09217-1, 09218-1, 09218, 09208, 09209, 09210, 09211, 09212, 06663HC, 09040, 09041, 09042, 09043, 099908, 099918, 09991MM, 09219-1, 09219, 09219HC, 09213 Umbra Medical Products Umbra Medical Products Dụng cụ mở đường vào mạch máu Quy tắc 7, Phần II, Phụ lục 1, TT 39/2016/TT-BYT TTBYT Loại C
7 CL – ELITETM Hemostasis Valve Introducer 09989, 09990, 09991, 09992, 09993, 09994, 09995, 09996, 09146, 09147, 09148, 09149, 09150, 09210, 09215, 09212, 09216, 09213, 09217, 09208, 09209, 09210, 09211, 09040, 09041, 09042, 09043, 099908, 099918,09991MM, 09312, 09315-1, 09422, 09424, 09426, 09427, 09428, 09985-1, 09986-1, 09987-1, 09988-1, 09989-1, 09990-1, 09991-1, 09992-1, 09993-1, 09997-1 Umbra Medical Products Umbra Medical Products Dụng cụ mở đường vào mạch máu Quy tắc 7, Phần II, Phụ lục 1, TT 39/2016/TT-BYT TTBYT Loại C
8 InMedfaltor 12030, 13100, 13101, 13102, 13103, 13104, 13105, 13106, 13107, 13108, 12021, 12100, 12101, 12102, 12103, 12104, 12105, 12106, 12107, 12108, 14100, 14101, 14102, 14103, 14104, 14105, 14106, 14107, 14108, 14109 Umbra Medical Products Umbra Medical Products Bộ bơm bóng áp lực cao Quy tắc 11, Phần II, Phụ lục 1, TT 39/2016/TT-BYT TTBYT Loại C
9 Assist - Cil 13050, 13051, 13052, 13053, 13054, 15031, 13000-B, 13001-B, 13002-B, 13003-B, 13004-B, 13010, 13011, 13012, 13013, 13014, 13020, 13021, 13022, 13023, 13024, 13030, 13026, 13027, 13028, 13029, 15030 Umbra Medical Products Umbra Medical Products Dây nối bơm tiêm cảm quang Quy tắc 11, Phần II, Phụ lục 1, TT 39/2016/TT-BYT TTBYT Loại C
10 Angioaid 89000 Umbra Medical Products Umbra Medical Products Miếng cầm máu mạch đùi Quy tắc 6, Phần II, Phụ lục 1, TT 39/2016/TT-BYT TTBYT Loại C