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Dialyzer (Dialysis Filter medium flux)
EUDAMEDClass IIb (EU MDR)
Ref 90423Model Dialyzer (Dialysis Filter medium flux)
Identity
- Trade Name
- Dialyzer (Dialysis Filter medium flux) EUDAMED
- Device Name
- Dialyzer (Dialysis Filter) EUDAMED
- Model / Reference
- Dialyzer (Dialysis Filter medium flux) EUDAMED90423 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095904237 EUDAMED
- Basic UDI-DI
- 890209590371GU EUDAMED
- EMDN Code
- F01060203 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb 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
Dialyzer (Dialysis Filter medium flux) by Poly Medicure Limited — 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 | 890209590371GU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043011
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c8640a1c-93e1-4440-a64e-1ae0238f7e28 61 fields · synced Jun 18, 2026