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Manifold Kit
EUDAMEDClass IIa (EU MDR)
Ref AM0351AModel 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.
Identity
- Device Name
- Manifold Kit 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. EUDAMEDAM0351A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950900920684 EUDAMED
- Basic UDI-DI
- 69509009CEMKSA EUDAMED
- EMDN Code
- C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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 — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 0a577eb8-68ce-4e3e-9e0f-7eb8ccf14403 61 fields · synced Jun 19, 2026