Membrane Oxygenator
by Tianjin Plastics Research Institute Co., Ltd. China EUDAMED
Ref 06944803673068Model /
EMDN C03010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6944803600130001GT | Date27 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- CN25/00007713 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 30 Apr 2026
- Expires
- 13 Nov 2030
- Reason
- Add device or group
Specification
- Device Name
- Membrane Oxygenator
- Model / Reference
- /, 06944803673068
- Primary DI / UDI-DI
- 06944803673068
- Basic UDI-DI
- 6944803600130001GT
- EMDN Code
- C03010102 Oxygenator kits
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000031209
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Tianjin Plastics Research Institute Co., Ltd.
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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 2710f2db-90d4-4a17-9882-e7a325100981