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Orteza stopowo-goleniowa “AIR WALKER DUOSHELL” LONG
EUDAMEDClass I (EU MDR)
Ref O-1751/XL/LModel O-1751Ref O-1186/MModel O-1186
Identity
- Trade Name
- Orteza stopowo-goleniowa “AIR WALKER DUOSHELL” LONG EUDAMEDOrteza stopowo-goleniowa “AIR WALKER DUOSHELL” LONG EUDAMED
- Device Name
- Orteza ręki i przedramienia z ujęciem kciuka „FlexLoopT” EUDAMEDOrteza stopowo-goleniowa “AIR WALKER DUOSHELL” LONG EUDAMED
- Model / Reference
- O-1751 EUDAMEDO-1751/XL/L EUDAMEDO-1186 EUDAMEDO-1186/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903940716527 EUDAMED05903940716374 EUDAMED
- Basic UDI-DI
- 59039407O1751EG EUDAMED59039407O1186E5 EUDAMED
- Direct Marketing DI
- 05903940716527 EUDAMED05903940716374 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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 stopowo-goleniowa “AIR WALKER DUOSHELL” LONG 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 (2)
- EUDAMED d26b6bfa-5f29-4695-8d8d-f6db35a6edc2 61 fields · synced Oct 6, 2026
- EUDAMED 78e8b67a-dd18-4c92-b827-6ed198fd27df 61 fields · synced May 19, 2026