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Hollow Fiber Dialyzer
EUDAMEDClass IIb (EU MDR)
Ref F14LPModel F14LP, F16LP, F18LP, F20LP, F22LP
Identity
- Trade Name
- Hollow Fiber Dialyzer EUDAMED
- Device Name
- Hollow Fiber Dialyzer EUDAMED
- Model / Reference
- F14LP, F16LP, F18LP, F20LP, F22LP EUDAMEDF14LP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562305085 EUDAMED
- Basic UDI-DI
- 69325623200054C EUDAMED
- EMDN Code
- F01060203 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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 Guangdong Biolight Meditech 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 | 69325623200054C | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f019298a-54a0-401d-8119-f2b361be35dd 61 fields · synced Jun 18, 2026