← Back to catalogue
Hollow Fiber Dialyzer
EUDAMEDClass IIb (EU MDR)
Ref F20HPModel F14HP, F16HP, F18HP, F20HP, F22HPRef F14HPRef F18LPModel F14LP, F16LP, F18LP, F20LP, F22LPRef F18HPRef F22HP
Identity
- Trade Name
- Hollow Fiber Dialyzer EUDAMED
- Device Name
- Hollow Fiber Dialyzer EUDAMED
- Model / Reference
- F14HP, F16HP, F18HP, F20HP, F22HP EUDAMEDF20HP EUDAMEDF14HP EUDAMEDF14LP, F16LP, F18LP, F20LP, F22LP EUDAMEDF18LP EUDAMEDF18HP EUDAMEDF22HP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562305160 EUDAMED06932562305139 EUDAMED06932562305108 EUDAMED06932562305153 EUDAMED06932562305177 EUDAMED
- Basic UDI-DI
- 69325623200074G EUDAMED69325623200054C EUDAMED
- EMDN Code
- F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMEDF01060203 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 | 69325623200074G | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 16a28ee1-b84e-4c2c-9630-4a775168ba73 61 fields · synced Aug 1, 2026
- EUDAMED 3e3ac405-511a-47c0-81ed-443a0778e40b 61 fields · synced May 16, 2026
- EUDAMED 3ea70d8b-59f3-4d76-b124-e8381c532f72 61 fields · synced May 17, 2026
- EUDAMED 1263d753-dd96-4410-84fc-da049b2d7830 61 fields · synced May 18, 2026
- EUDAMED b7c6773c-42ff-4686-834f-6498651e770c 61 fields · synced May 18, 2026