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Orteza stopowo-goleniowa, niska. Walker Pro
EUDAMEDClass I (EU MDR)
Ref AR-601Model Orteza
Identity
- Trade Name
- Orteza stopowo-goleniowa, niska. Walker Pro EUDAMED
- Model / Reference
- Orteza EUDAMEDAR-601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907713380014 EUDAMED05907713380021 EUDAMED05907713380038 EUDAMED05907713380007 EUDAMED
- Basic UDI-DI
- 590771338O001C3 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, niska. Walker Pro by Armedical Spółka Z Ograniczoną Odpowiedzialnością — Class I — MDR — listed in EUDAMED
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Also classified as Ankle/foot orthosis.
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- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
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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 | 590771338O001C3 | Class I | Active |
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Manufacturer
- Manufacturer
- Armedical Spółka Z Ograniczoną Odpowiedzialnością
- EUDAMED SRN
- PL-MF-000036062
Sources (4)
- EUDAMED 4d700783-36d9-4050-8e1c-506b1c1be022 61 fields · synced Oct 5, 2026
- EUDAMED 14dfcbfe-d933-42b4-b98a-d44d74cbf738 61 fields · synced May 17, 2026
- EUDAMED da4433b6-a35c-4070-9a2c-07b18758abda 61 fields · synced May 17, 2026
- EUDAMED c0d54062-961e-4f03-8f14-16bd02fe5ebc 61 fields · synced May 19, 2026