Membrane Oxygenator
by Tianjin Plastics Research Institute Co., Ltd. 22 variants
Ref 06944803672948Model /
Active
CE MDR
Valid until
13 Nov 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6944803600130001GT 06944803672948 | Date27 May 2026 | StatusActive |
Certificates
- CN25/00007713 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 30 Apr 2026
- Expires
- 13 Nov 2030
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Membrane Oxygenator
- Model / Reference
- /, 06944803672948
- Primary DI / UDI-DI
- 06944803672948
- Basic UDI-DI
- 6944803600130001GT
- EMDN Code
- C03010102 Oxygenator kits
- Device Class
- Class IIa
- EU market of registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- CN-MF-000031209
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Tianjin Plastics Research Institute Co., Ltd.
See all devices from Tianjin Plastics Research Institute Co., Ltd. →
Properties
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