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Dialyzer (Dialysis Filter low flux)
EUDAMEDClass IIb (EU MDR)
Ref 90390Model Dialyzer (Dialysis Filter low flux)Ref 90418Ref 90383Ref 90392Ref 90419Ref 90378Ref 90389Ref 90394Ref 90367Ref 90380Ref 90402Ref 90377Ref 90416Ref 90391Ref 90382Ref 90365Ref 90415Ref 90399Ref 90404
Identity
- Trade Name
- Dialyzer (Dialysis Filter low flux) EUDAMED
- Device Name
- Dialyzer (Dialysis Filter) EUDAMED
- Model / Reference
- Dialyzer (Dialysis Filter low flux) EUDAMED90390 EUDAMED90418 EUDAMED90383 EUDAMED90392 EUDAMED90419 EUDAMED90378 EUDAMED90389 EUDAMED90394 EUDAMED90367 EUDAMED90380 EUDAMED90402 EUDAMED90377 EUDAMED90416 EUDAMED90391 EUDAMED90382 EUDAMED90365 EUDAMED90415 EUDAMED90399 EUDAMED90404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095903902 EUDAMED08902095904183 EUDAMED08902095903834 EUDAMED08902095903926 EUDAMED08902095904190 EUDAMED08902095903780 EUDAMED08902095903896 EUDAMED08902095903940 EUDAMED08902095903674 EUDAMED08902095903803 EUDAMED08902095904022 EUDAMED08902095903773 EUDAMED08902095904169 EUDAMED08902095903919 EUDAMED08902095903827 EUDAMED08902095903650 EUDAMED08902095904152 EUDAMED08902095903995 EUDAMED08902095904046 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 (19)
- EUDAMED 5eff7043-ba3b-49c6-8729-1d4634473e7a 61 fields · synced Jul 30, 2026
- EUDAMED bf9e4cc2-b96d-4ffa-8414-23e9077efa21 61 fields · synced May 11, 2026
- EUDAMED df167183-ed1e-4d28-9216-31951aa85032 61 fields · synced May 11, 2026
- EUDAMED 1ab09e13-c4bc-486a-8f47-3994e1b1db74 61 fields · synced May 11, 2026
- EUDAMED dad5815e-0b55-42ba-b0a5-f898b16ee65a 61 fields · synced May 16, 2026
- EUDAMED d5e0261d-c6f7-4df5-8579-0b387955835b 61 fields · synced May 16, 2026
- EUDAMED 94b576ad-8d60-4069-bc9f-e816f273f234 61 fields · synced May 17, 2026
- EUDAMED 78be7010-1170-4180-b26b-00bd61187b25 61 fields · synced May 17, 2026
- EUDAMED 9930fd5d-619a-4759-8087-4326ef249deb 61 fields · synced May 18, 2026
- EUDAMED 571e0c24-fdce-4ca7-b268-1da2ed2283d2 61 fields · synced May 18, 2026
- EUDAMED 469613a4-aa56-4c68-b47a-10a8639a8a48 61 fields · synced May 18, 2026
- EUDAMED 80dc49eb-dec3-40c7-9e44-ac96ce81f6b5 61 fields · synced May 18, 2026
- EUDAMED ee095108-f889-4d49-a783-a8b7dec3ad23 61 fields · synced May 18, 2026
- EUDAMED ab371bb8-01ae-4aa9-b284-418064554bc4 61 fields · synced May 18, 2026
- EUDAMED a5aa1f21-cf9e-4198-9d32-018adff3e105 61 fields · synced May 18, 2026
- EUDAMED 087929b8-de70-459e-9a23-1141582860d3 61 fields · synced May 18, 2026
- EUDAMED 4850f1ff-92e5-4ddf-8ea7-33a4916f7b05 61 fields · synced May 18, 2026
- EUDAMED 7246f375-7727-48da-8eeb-ee105106475f 61 fields · synced May 18, 2026
- EUDAMED 9b48a225-80bf-474e-87ed-b0d3e8966187 61 fields · synced May 19, 2026