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Manifold Kit
EUDAMEDClass IIa (EU MDR)
Ref AM0250Model AM0250, AM0251, AM0350, AM0351, AM0351A, AM0351C, AM0351D, AM0352, AM0352A, AM0352E, AM0352G, AM0352J, AM0353, AM0352H, AM0351-G, AM0352F, AM0352F-1, AM0351F, AM0352L, AM0352M, AM0352N, AM0352P, AM0352B, AM0352C, AM0352D.Ref AM02Model AM02, AM03, AM04Ref AM0352JRef AM0352BRef AM0352LRef AM0209Ref AM0311Ref AM0352CRef AM0401Ref AM0309ARef AM0310Ref AM0352GRef AM0352F-1Ref AM0352MRef AM0350Ref AM0303ARef AM0251Ref AM0402Ref AM0351DRef AM0309Ref AM0304Ref AM0308Ref AM0351FRef AM0352ARef AM0352ERef AM0353Ref AM0303Ref AM0351-GRef AM0310A
Identity
- Trade Name
- Manifold Kit EUDAMEDManifold EUDAMED
- Device Name
- Manifold Kit EUDAMEDManifold EUDAMED
- Model / Reference
- AM0250, AM0251, AM0350, AM0351, AM0351A, AM0351C, AM0351D, AM0352, AM0352A, AM0352E, AM0352G, AM0352J, AM0353, AM0352H, AM0351-G, AM0352F, AM0352F-1, AM0351F, AM0352L, AM0352M, AM0352N, AM0352P, AM0352B, AM0352C, AM0352D. EUDAMEDAM0250 EUDAMEDAM02, AM03, AM04 EUDAMEDAM02 EUDAMEDAM0352J EUDAMEDAM0352B EUDAMEDAM0352L EUDAMEDAM0209 EUDAMEDAM0311 EUDAMEDAM0352C EUDAMEDAM0401 EUDAMEDAM0309A EUDAMEDAM0310 EUDAMEDAM0352G EUDAMEDAM0352F-1 EUDAMEDAM0352M EUDAMEDAM0350 EUDAMEDAM0303A EUDAMEDAM0251 EUDAMEDAM0402 EUDAMEDAM0351D EUDAMEDAM0309 EUDAMEDAM0304 EUDAMEDAM0308 EUDAMEDAM0351F EUDAMEDAM0352A EUDAMEDAM0352E EUDAMEDAM0353 EUDAMEDAM0303 EUDAMEDAM0351-G EUDAMEDAM0310A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950900922046 EUDAMEDD-ManifoldCS EUDAMED06950900961397 EUDAMED06950900920714 EUDAMED06950900901904 EUDAMED06950900933646 EUDAMED06950900965357 EUDAMED06942033969968 EUDAMED06950900920455 EUDAMED06950900996009 EUDAMED06950900921780 EUDAMED06950900922367 EUDAMED06950900982156 EUDAMED06950900999970 EUDAMED06950900920677 EUDAMED06950900906831 EUDAMED06950900923487 EUDAMED06950900920462 EUDAMED06950900930201 EUDAMED06950900923012 EUDAMED06950900920400 EUDAMED06950900920431 EUDAMED06942033969951 EUDAMED06950900920707 EUDAMED06950900961380 EUDAMED06950900941320 EUDAMED06950900920394 EUDAMED06942033969944 EUDAMED06942033937561 EUDAMED
- Basic UDI-DI
- 69509009CEMKSA EUDAMEDB-ManifoldCS EUDAMED69509009CEMNSG EUDAMED
- EMDN Code
- C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMEDA0799 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular guidewire introduction sleeve
Manifold Kit by Shanghai INT Medical Instruments Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69509009CEMKSA | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69509009CEMKSA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai INT Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000009966
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (30)
- EUDAMED 2ca1d124-7d95-4ef5-b7fe-76a258aca5eb 61 fields · synced Sep 18, 2026
- EUDAMED e65e08f0-6882-4b7d-8fb9-281a0280c592 61 fields · synced May 19, 2026
- EUDAMED 11e522cc-4a4b-4d3a-acd5-b1cba1fe4f5c 61 fields · synced Jun 20, 2026
- EUDAMED a6c0eb36-fdc3-4d90-96b4-03a6ac4780d2 61 fields · synced Jun 20, 2026
- EUDAMED 5e36146a-31e9-400d-813c-16d4d305521e 61 fields · synced Jun 20, 2026
- EUDAMED cb3cd792-b54b-409e-a588-6144b5bae165 61 fields · synced Jun 20, 2026
- EUDAMED 73544424-6545-4b15-b90e-ccc20694219a 61 fields · synced Jul 9, 2026
- EUDAMED 8de1d528-16a0-438a-8897-e34d0440e438 61 fields · synced Jul 9, 2026
- EUDAMED 3e22ecd4-348f-452d-87d8-054e92d91594 61 fields · synced Jul 9, 2026
- EUDAMED 9a3b34b5-73de-4ceb-91f0-61cee26c50ca 61 fields · synced Jul 10, 2026
- EUDAMED 9daea91a-f8e0-4bdd-b83c-a6443badb9b7 61 fields · synced Jul 10, 2026
- EUDAMED 5dc5997a-b136-41a9-8f0b-872dee5d5ee4 61 fields · synced Jul 10, 2026
- EUDAMED a7dcdd27-7b11-468c-b974-51e57c044d0c 61 fields · synced Jul 10, 2026
- EUDAMED e9a94e1d-a0d6-42e4-bd34-9b31515c90e0 61 fields · synced Jul 11, 2026
- EUDAMED c14f8a81-292e-4675-a603-e5aacf320cbe 61 fields · synced Jul 12, 2026
- EUDAMED 2018077c-5702-467d-a46a-8466edf3ac77 61 fields · synced Jul 18, 2026
- EUDAMED 8c3d8b40-e889-4df8-9049-2be90c063aeb 61 fields · synced Jul 19, 2026
- EUDAMED f9a34f9b-a1fd-4171-955f-cb993b0006e5 61 fields · synced Jul 20, 2026
- EUDAMED d0d54547-714a-4c77-b6dd-474d63d9522c 61 fields · synced Jul 20, 2026
- EUDAMED 04c3c1e7-25d4-4fb9-8c78-a159d66a0a3a 61 fields · synced Jul 21, 2026
- EUDAMED 56d54dee-88c3-4f39-8566-17439fcae3aa 61 fields · synced Jul 22, 2026
- EUDAMED 93ab15b7-3859-4c40-ad99-74ed8dfb66cf 61 fields · synced Jul 24, 2026
- EUDAMED ced25097-e0b5-4138-8d59-915ce99ba37a 61 fields · synced Jul 25, 2026
- EUDAMED b54fc5dd-aecd-4343-948a-3bed0a5b879d 61 fields · synced Jul 27, 2026
- EUDAMED 5eaa162e-4678-454c-86fb-121eb0b15577 61 fields · synced Jul 27, 2026
- EUDAMED 08b11a52-8fc3-4fc0-8589-8b0f0fd40ea3 61 fields · synced Jul 29, 2026
- EUDAMED 9ff47f65-6850-42b2-895c-a62b76287f79 61 fields · synced Jul 31, 2026
- EUDAMED 080f3ef6-f2f9-4390-92f6-3ce3592a31ca 61 fields · synced Aug 3, 2026
- EUDAMED 00d6ea62-401c-4ffe-92d9-fc9eb54e62b7 61 fields · synced Aug 4, 2026
- EUDAMED 26195aba-eae6-4bbb-91ab-87806d08c025 61 fields · synced Sep 18, 2026