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Hollow Fiber Dialyzer
EUDAMEDClass IIb (EU MDR)
Ref B-14HFModel B-14HF, B-16HF, B-18HF, B-20HF, B-21HF, B-22HF, B-24HF
Identity
- Trade Name
- Hollow Fiber Dialyzer EUDAMED
- Device Name
- Hollow Fiber Dialyzer EUDAMED
- Model / Reference
- B-14HF, B-16HF, B-18HF, B-20HF, B-21HF, B-22HF, B-24HF EUDAMEDB-14HF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948082700927 EUDAMED
- Basic UDI-DI
- 6948082703422AK EUDAMED
- EMDN Code
- F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
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
Hollow Fiber Dialyzer by Bain Medical Equipment(Guangzhou)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 | 6948082703422AK | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bain Medical Equipment(Guangzhou)Co., Ltd.
- EUDAMED SRN
- CN-MF-000005196
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED da3c6826-35e7-4bf1-968e-b99753abce89 61 fields · synced Oct 5, 2026