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Dialyzer (Dialysis Filter high flux)
EUDAMEDClass IIb (EU MDR)
Ref 90477Model Dialyzer (Dialysis Filter high flux)
Identity
- Trade Name
- Dialyzer (Dialysis Filter high flux) EUDAMED
- Device Name
- Dialyzer (Dialysis Filter) EUDAMED
- Model / Reference
- Dialyzer (Dialysis Filter high flux) EUDAMED90477 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095904770 EUDAMED
- Basic UDI-DI
- 890209590369H9 EUDAMED
- EMDN Code
- F01060303 DIALYSERS - UFC > 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 high 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 | 890209590369H9 | 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 65dc6e1c-915d-48f3-82ce-003a895f531d 61 fields · synced Jun 18, 2026