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Orteza stopowo-goleniowa ″AIR WALKER DUOSHELL″ SHORT
EUDAMEDClass I (EU MDR)
Ref O-1187/XLModel O-1187
Identity
- Trade Name
- Orteza stopowo-goleniowa ″AIR WALKER DUOSHELL″ SHORT EUDAMED
- Device Name
- Orteza stopowo-goleniowa ″AIR WALKER DUOSHELL″ SHORT EUDAMED
- Model / Reference
- O-1187 EUDAMEDO-1187/XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903940716442 EUDAMED
- Basic UDI-DI
- 59039407O1187E7 EUDAMED
- Direct Marketing DI
- 05903940716442 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
Category: Ankle/foot orthosis
Orteza stopowo-goleniowa ″AIR WALKER DUOSHELL″ SHORT by REHA FUND Sp. z o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · Class I
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 | 59039407O1187E7 | Class I | Active |
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Manufacturer
- Manufacturer
- REHA FUND Sp. z o.o.
- EUDAMED SRN
- PL-MF-000047481
Sources (1)
- EUDAMED 1c059bcb-955c-4b2b-83f1-ed1a62650110 61 fields · synced Oct 8, 2026