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 |
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 |
2 |
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 |
3 |
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 |
4 |
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 |
5 |
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 |
6 |
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 |
7 |
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 |
8 |
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 |
9 |
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
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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 |
|