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Dialyzer (Dialysis Filter high flux)
EUDAMEDClass IIb (EU MDR)
Ref 90443Model Dialyzer (Dialysis Filter high flux)Ref 90411Ref 90414Ref 90431Ref 90445Ref 90410Ref 90437Ref 90476Ref 90444Ref 90395Ref 90428Ref 90425Ref 90427Ref 90387Ref 90436Ref 90381
Identity
- Trade Name
- Dialyzer (Dialysis Filter high flux) EUDAMED
- Device Name
- Dialyzer (Dialysis Filter) EUDAMED
- Model / Reference
- Dialyzer (Dialysis Filter high flux) EUDAMED90443 EUDAMED90411 EUDAMED90414 EUDAMED90431 EUDAMED90445 EUDAMED90410 EUDAMED90437 EUDAMED90476 EUDAMED90444 EUDAMED90395 EUDAMED90428 EUDAMED90425 EUDAMED90427 EUDAMED90387 EUDAMED90436 EUDAMED90381 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095904435 EUDAMED08902095904114 EUDAMED08902095904145 EUDAMED08902095904312 EUDAMED08902095904459 EUDAMED08902095904107 EUDAMED08902095904374 EUDAMED08902095904763 EUDAMED08902095904442 EUDAMED08902095903957 EUDAMED08902095904282 EUDAMED08902095904251 EUDAMED08902095904275 EUDAMED08902095903872 EUDAMED08902095904367 EUDAMED08902095903810 EUDAMED
- Basic UDI-DI
- 890209590369H9 EUDAMED
- EMDN Code
- F01060303 DIALYSERS - UFC > 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 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 (16)
- EUDAMED ba287716-2e19-47f1-9aa6-30b15e92920e 61 fields · synced Sep 18, 2026
- EUDAMED b7ead9ab-a3e5-4477-99c3-7c15ef675034 61 fields · synced May 16, 2026
- EUDAMED 9119d6be-e941-4bf9-ac66-cb6f1b4836d2 61 fields · synced May 16, 2026
- EUDAMED b006b86f-acc4-4edf-b139-6b0c8a978aed 61 fields · synced May 16, 2026
- EUDAMED facdd67e-5e40-4898-b371-cd51780ed723 61 fields · synced May 17, 2026
- EUDAMED e19440fe-605b-47ab-af75-811133b00890 61 fields · synced May 17, 2026
- EUDAMED 4fd7b5d9-e745-4c6c-804c-3c2e0ef12948 61 fields · synced May 17, 2026
- EUDAMED d365d3b2-086c-4605-a856-cfbdb72a4524 61 fields · synced May 17, 2026
- EUDAMED 17c00fe6-1616-4ed1-b3b2-41829df6ae90 61 fields · synced May 17, 2026
- EUDAMED 44d3d333-8e6e-4b12-ac59-286fa5064b4c 61 fields · synced May 18, 2026
- EUDAMED ff155fc5-f623-44e7-81a6-688e931ce7ef 61 fields · synced May 18, 2026
- EUDAMED 931ca026-10b6-44d5-b899-76e06f192b84 61 fields · synced May 18, 2026
- EUDAMED 98440a0c-9bd6-4f96-8deb-5b96b442fa32 61 fields · synced May 18, 2026
- EUDAMED 8d6057c3-2ff0-4717-bebf-4ae41000f183 61 fields · synced May 18, 2026
- EUDAMED 94f4b56c-2a78-44ae-a748-6a52dfba49f8 61 fields · synced May 18, 2026
- EUDAMED 48a5cc27-c600-46e5-b579-4d4744ca5da1 61 fields · synced May 19, 2026