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Dialyzer (Dialysis Filter low flux)
EUDAMEDClass IIb (EU MDR)
Ref 90368Model Dialyzer (Dialysis Filter low flux)
Identity
- Trade Name
- Dialyzer (Dialysis Filter low flux) EUDAMED
- Device Name
- Dialyzer (Dialysis Filter) EUDAMED
- Model / Reference
- Dialyzer (Dialysis Filter low flux) EUDAMED90368 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095903681 EUDAMED
- Basic UDI-DI
- 890209590365GZ EUDAMED
- EMDN Code
- F01060103 DIALYSERS - UFC < 18 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 low 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 | 890209590365GZ | 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 2c3c2bea-616b-4ce3-a53f-dadd92d479fe 61 fields · synced Jun 17, 2026