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Orteza ręki i przedramienia z ujęciem kciuka ″FlexLoopT″
EUDAMEDClass I (EU MDR)
Ref O-1751/XL/PModel O-1751Ref O-1751/L/LRef O-1751/S/PRef O-1751/M/LRef O-1751/XS/LRef O-1751/L/PRef O-1751/XS/P
Identity
- Trade Name
- Orteza ręki i przedramienia z ujęciem kciuka ″FlexLoopT″ EUDAMED
- Device Name
- Orteza ręki i przedramienia z ujęciem kciuka „FlexLoopT” EUDAMED
- Model / Reference
- O-1751 EUDAMEDO-1751/XL/P EUDAMEDO-1751/L/L EUDAMEDO-1751/S/P EUDAMEDO-1751/M/L EUDAMEDO-1751/XS/L EUDAMEDO-1751/L/P EUDAMEDO-1751/XS/P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903940716572 EUDAMED05903940716510 EUDAMED05903940716541 EUDAMED05903940716503 EUDAMED05903940716480 EUDAMED05903940716565 EUDAMED05903940716534 EUDAMED
- Basic UDI-DI
- 59039407O1751EG EUDAMED
- Direct Marketing DI
- 05903940716572 EUDAMED05903940716510 EUDAMED05903940716541 EUDAMED05903940716503 EUDAMED05903940716480 EUDAMED05903940716565 EUDAMED05903940716534 EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) 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
Orteza ręki i przedramienia z ujęciem kciuka ″FlexLoopT″ 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 | 59039407O1751EG | Class I | Active |
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Manufacturer
- Manufacturer
- REHA FUND Sp. z o.o.
- EUDAMED SRN
- PL-MF-000047481
Sources (7)
- EUDAMED f93e1717-dd6f-45aa-874f-9038f569285b 61 fields · synced Oct 8, 2026
- EUDAMED c067d913-eb75-420e-b4d9-7bab365fe857 61 fields · synced May 16, 2026
- EUDAMED f3fcd776-1c72-47b5-8261-007043327037 61 fields · synced May 17, 2026
- EUDAMED c908052f-eab4-42fc-a1d5-20f7587fe043 61 fields · synced May 17, 2026
- EUDAMED 4c011a0d-f71c-4d92-a11d-6bee855ec83f 61 fields · synced May 17, 2026
- EUDAMED fa1539a1-7f52-4fde-9a3a-4d04860e0509 61 fields · synced May 17, 2026
- EUDAMED 3528f86f-f915-451a-876a-5a88a5e4e74c 61 fields · synced May 18, 2026