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Sterile Disposable Plasma Apheresis Set
EUDAMEDClass IIb (EU MDR)
Ref F-10005A1
Identity
- Device Name
- Sterile Disposable Plasma Apheresis Set EUDAMED
- Model / Reference
- F-10005A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970494389476 EUDAMED
- Basic UDI-DI
- 697049438ZBKFLQ01KV EUDAMED
- EMDN Code
- B030201 PLASMAPHERESIS DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Disposable Plasma Apheresis Set by Shandong Zhongbaokang Medical Implements Co., Ltd. — Class IIb — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697049438ZBKFLQ01KV | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shandong Zhongbaokang Medical Implements Co., Ltd.
- EUDAMED SRN
- CN-MF-000013907
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e4e26473-ad0c-493b-b2ec-2dbb8147de81 61 fields · synced Jun 18, 2026