Identity
- Device Name
- Sterile Leukocyte Reduction Filters EUDAMED
- Model / Reference
- ZBK-H-500B2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970494389889 EUDAMED
- Basic UDI-DI
- 697049438ZBKQB015C EUDAMED
- EMDN Code
- B02010201 LABORATORY ERYTHROCYTES (RBC) LEUKOREDUCTION FILTERS 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 Leukocyte Reduction Filters by Shandong Zhongbaokang Medical Implements Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697049438ZBKQB015C | 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 7f8131d0-ae7b-4e40-bff8-29493f7e8780 61 fields · synced Oct 7, 2026