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Sterile Disposable Plasma Apheresis Set
EUDAMEDClass IIb (EU MDR)
Ref F-10007A3Ref F-10007A3TRef F-10007A1TRef F-12003A1TRef F-10005E1TRef F-10006A3TRef F-10002D1TRef F-8005A1Ref F-12006A1TRef F-12002AModel F-1200C， F-12002ARef F-10003D1TRef F-8006A1
Identity
- Device Name
- Sterile Disposable Plasma Apheresis Set EUDAMED
- Model / Reference
- F-10007A3 EUDAMEDF-10007A3T EUDAMEDF-10007A1T EUDAMEDF-12003A1T EUDAMEDF-10005E1T EUDAMEDF-10006A3T EUDAMEDF-10002D1T EUDAMEDF-8005A1 EUDAMEDF-12006A1T EUDAMEDF-1200C， F-12002A EUDAMEDF-12002A EUDAMEDF-10003D1T EUDAMEDF-8006A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970494389636 EUDAMED06970494389414 EUDAMED06970494389438 EUDAMED06970494389513 EUDAMED06970494389452 EUDAMED06970494389391 EUDAMED06970494389599 EUDAMED06970494389650 EUDAMED06970494389537 EUDAMED06970494389568 EUDAMED06970494389520 EUDAMED06970494389643 EUDAMED
- Basic UDI-DI
- 697049438ZBKFLQ01KV EUDAMED697049438ZBKFLQ02KX 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
EUDAMEDEUDAMED
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 (12)
- EUDAMED 1817ba57-ee7b-4db6-9062-f6280d97b9ac 61 fields · synced Oct 5, 2026
- EUDAMED fac03adb-9244-4389-b593-6ba3cbd31571 61 fields · synced May 17, 2026
- EUDAMED 0bc472de-860a-420e-bfac-76d7e2fd0e9f 61 fields · synced May 17, 2026
- EUDAMED b53315bc-48cb-4750-953d-7d719f25715f 61 fields · synced May 17, 2026
- EUDAMED 0acf0602-d685-46ea-9028-50b130fd1dff 61 fields · synced May 17, 2026
- EUDAMED fa1e1d9f-f353-4467-9f4c-9fd33e6db4c3 61 fields · synced May 18, 2026
- EUDAMED 1db5fab8-0bbf-4248-a07a-78342b0c517f 61 fields · synced May 18, 2026
- EUDAMED 3e72138d-9842-4334-9924-e00800b04567 61 fields · synced May 18, 2026
- EUDAMED 75214959-35e8-4477-a0cb-f91d475ed558 61 fields · synced May 18, 2026
- EUDAMED b0ca76bf-e923-4cfc-a225-759f02eeb2e0 61 fields · synced May 18, 2026
- EUDAMED 61b21e51-91cd-484a-9727-3cdebcc80bbd 61 fields · synced May 19, 2026
- EUDAMED f1063b67-63ef-4006-b7e5-97f7e9379b21 61 fields · synced May 19, 2026