Manifold Kit
by Shanghai INT Medical Instruments Co., Ltd. China EUDAMED
Ref AM0350Model 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.
EMDN C010480
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69509009CEMKSA | Date24 Mar 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Manifold Kit
- 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.
- Primary DI / UDI-DI
- 06950900920677
- Basic UDI-DI
- 69509009CEMKSA
- EMDN Code
- C010480 Angiography and hemodynamics devices - accessories not included in other classes
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000009966
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 2018077c-5702-467d-a46a-8466edf3ac77