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Dialyzer (Dialysis Filter medium flux)
EUDAMEDClass IIb (EU MDR)
Ref 90480Model Dialyzer (Dialysis Filter medium flux)Ref 90438Ref 90478Ref 90386Ref 90440Ref 90408Ref 90384Ref 90409Ref 90441Ref 90405Ref 90479Ref 90421
Identity
- Trade Name
- Dialyzer (Dialysis Filter medium flux) EUDAMED
- Device Name
- Dialyzer (Dialysis Filter) EUDAMED
- Model / Reference
- Dialyzer (Dialysis Filter medium flux) EUDAMED90480 EUDAMED90438 EUDAMED90478 EUDAMED90386 EUDAMED90440 EUDAMED90408 EUDAMED90384 EUDAMED90409 EUDAMED90441 EUDAMED90405 EUDAMED90479 EUDAMED90421 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095904800 EUDAMED08902095904381 EUDAMED08902095904787 EUDAMED08902095903865 EUDAMED08902095904404 EUDAMED08902095904084 EUDAMED08902095903841 EUDAMED08902095904091 EUDAMED08902095904411 EUDAMED08902095904053 EUDAMED08902095904794 EUDAMED08902095904213 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
- Market of Registration
- Germany 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 (12)
- EUDAMED a19f4d7a-ea5b-4163-9c18-bffb512e7569 61 fields · synced Jul 28, 2026
- EUDAMED 89d72185-0a23-4d1f-8411-e93e4d90df61 61 fields · synced May 17, 2026
- EUDAMED 1d8a7789-8623-46c7-9ba2-20e207bb2135 61 fields · synced May 17, 2026
- EUDAMED 8e8c9995-1d6f-4336-8777-3fdcce5ee4de 61 fields · synced May 17, 2026
- EUDAMED 4b95b2d9-7874-4dcf-987d-e36ae06b53f2 61 fields · synced May 17, 2026
- EUDAMED 90ccbc61-c05f-461f-8704-bf04acd9d55a 61 fields · synced May 17, 2026
- EUDAMED 387c2057-bcc8-4531-9ed0-36eb91598024 61 fields · synced May 17, 2026
- EUDAMED 0984bbcd-5b72-420c-8abc-f1f6c837c462 61 fields · synced May 17, 2026
- EUDAMED ff53454a-5738-40fe-98c6-503ebb8a666f 61 fields · synced May 18, 2026
- EUDAMED 5cdcf965-72e5-4a42-9006-32acd6b9f254 61 fields · synced May 18, 2026
- EUDAMED 8b85eb0a-0e89-4035-a133-95e55643a869 61 fields · synced May 18, 2026
- EUDAMED 6e86b921-939d-4e1f-9115-665549cd8f7d 61 fields · synced May 19, 2026