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Orteza stopowo-goleniowa, dwukomorowa - niska. Walker Dual Comfort
EUDAMEDClass I (EU MDR)
Ref AR-607Model Orteza
Identity
- Trade Name
- Orteza stopowo-goleniowa, dwukomorowa - niska. Walker Dual Comfort EUDAMED
- Model / Reference
- Orteza EUDAMEDAR-607 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907713384609 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, dwukomorowa - niska. Walker Dual Comfort 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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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 (1)
- EUDAMED 6db703eb-43fd-4c1b-b3f9-5af57752a56b 61 fields · synced Oct 7, 2026