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Disposable Blood Filter
EUDAMEDClass IIa (EU MDR)
Ref BFA40-S, BFA40-L, BFA20-S, BFA20-L
Identity
- Trade Name
- Disposable Blood Filter EUDAMED
- Device Name
- Disposable Blood Filter EUDAMED
- Model / Reference
- BFA40-S, BFA40-L, BFA20-S, BFA20-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-BFABQ EUDAMED
- Basic UDI-DI
- B-BFABQ EUDAMED
- EMDN Code
- B0299 BLOOD FILTERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Blood Filter by Beijing ZKSK Technology Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-BFABQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 1dd182d3-929f-469d-b0af-c4deb5311b4c 61 fields · synced Oct 8, 2026
- EUDAMED 1dd182d3-929f-469d-b0af-c4deb5311b4c-1 61 fields · synced Jun 10, 2026