Disposable Blood Component Apheresis Set
by Sichuan Nigale Biotechnology Co., Ltd. China EUDAMED
Ref 10Model P-2000ⅠD, P-2000ⅠB, P-2000ⅠV, P-2000ⅠA, P-2000ⅠR, P-2000ⅠE, P-2000ⅠQ, P-2000ⅠP EMDN B030104
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06970658700109 | Date11 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- Disposable Blood Component Apheresis Set
- Model / Reference
- P-2000ⅠD, 10, P-2000ⅠB, P-2000ⅠV, P-2000ⅠA, P-2000ⅠR, P-2000ⅠE, P-2000ⅠQ, P-2000ⅠP
- Primary DI / UDI-DI
- 06970658700109, 06970658700079, 06970658700604, 06970658700055, 06970658700352, 06970658700116, 06970658700345, 06970658700338
- Basic UDI-DI
- B-06970658700109, B-06970658700079, B-06970658700604, B-06970658700055, B-06970658700352, B-06970658700116, B-06970658700345, B-06970658700338
- EMDN Code
- B030104 Apheresis multiple blood component collection devices
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000015825
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Sichuan Nigale Biotechnology Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (8)
- EUDAMED cb205851-89ee-4017-ab40-deb4ce7da0fc
- EUDAMED 06970658700079|B-06970658700079
- EUDAMED 06970658700604|B-06970658700604
- EUDAMED 06970658700055|B-06970658700055
- EUDAMED 06970658700352|B-06970658700352
- EUDAMED 06970658700116|B-06970658700116
- EUDAMED 06970658700345|B-06970658700345
- EUDAMED 06970658700338|B-06970658700338