Disposable Plasma Apheresis Set
by Sichuan Nigale Biotechnology Co., Ltd. EUDAMED
Active
Ref 10Model P-4004, P-4217, P-6005, P-4011, P-5000, P-4013, P-4025, P-4027, P-4026, P-4014, P-4018, P-4021, P-3001, P-4009, P-4019
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06970658701687 | Date10 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- Disposable Plasma Apheresis Set
- Model / Reference
- P-4004, 10, P-4217, P-6005, P-4011, P-5000, P-4013, P-4025, P-4027, P-4026, P-4014, P-4018, P-4021, P-3001, P-4009, P-4019
- Primary DI / UDI-DI
- 06970658701687, 06970658702455, 06970658702516, 06970658702325, 06970658700765, 06970658702332, 06970658702394, 06970658702417, 06970658702400, 06970658702349, 06970658702370, 06970658702387, 06970658700772, 06970658700734, 06970658700741
- Basic UDI-DI
- B-06970658701687, B-06970658702455, B-06970658702516, B-06970658702325, B-06970658700765, B-06970658702332, B-06970658702394, B-06970658702417, B-06970658702400, B-06970658702349, B-06970658702370, B-06970658702387, B-06970658700772, B-06970658700734, B-06970658700741
- EMDN Code
- B030101 Apheresis plasma collection devices
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000015825
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No