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Funkcjonalna Orteza Stawu Kolanowego ”duomax”
EUDAMEDClass I (EU MDR)
Ref O-1280/XL/LModel O-1280Ref O-1280/L/PRef O-1280/XL/PRef O-1280/L/LRef O-1280/M/P
Identity
- Trade Name
- FUNKCJONALNA ORTEZA STAWU KOLANOWEGO ”DUOMAX” EUDAMED
- Device Name
- Funkcjonalna orteza stawu kolanowego „Duomax” EUDAMED
- Model / Reference
- O-1280 EUDAMEDO-1280/XL/L EUDAMEDO-1280/L/P EUDAMEDO-1280/XL/P EUDAMEDO-1280/L/L EUDAMEDO-1280/M/P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903940712437 EUDAMED05903940712413 EUDAMED05903940712420 EUDAMED05903940712406 EUDAMED05903940712383 EUDAMED
- Basic UDI-DI
- 59039407O1280DW EUDAMED
- Direct Marketing DI
- 05903940712437 EUDAMED05903940712413 EUDAMED05903940712420 EUDAMED05903940712406 EUDAMED05903940712383 EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Funkcjonalna Orteza Stawu Kolanowego ”duomax” by REHA FUND Sp. z o.o. — Class I — 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 | 59039407O1280DW | Class I | Active |
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Manufacturer
- Manufacturer
- REHA FUND Sp. z o.o.
- EUDAMED SRN
- PL-MF-000047481
Sources (5)
- EUDAMED 94d75a57-3a7b-43aa-9a9b-41412fc2c2ce 61 fields · synced Oct 6, 2026
- EUDAMED 4c031543-4766-45f8-a0ca-61f74c95c6f2 61 fields · synced May 16, 2026
- EUDAMED f16707ba-e2d9-403a-be61-67f9b6365ee2 61 fields · synced May 17, 2026
- EUDAMED c5a54908-0f04-451f-8d67-219e6f176cbb 61 fields · synced May 17, 2026
- EUDAMED e1caaf05-d919-4010-b418-7906efd125fe 61 fields · synced May 18, 2026