← Back to catalogue
Orteza stopowo-goleniowa, dwukomorowa - wysoka. Walker Dual Comfort
EUDAMEDClass I (EU MDR)
Ref AR-608Model Orteza
Identity
- Trade Name
- Orteza stopowo-goleniowa, dwukomorowa - wysoka. Walker Dual Comfort EUDAMED
- Model / Reference
- Orteza EUDAMEDAR-608 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907713384654 EUDAMED05907713384647 EUDAMED05907713384623 EUDAMED05907713384630 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 - wysoka. Walker Dual Comfort by Armedical Spółka Z Ograniczoną Odpowiedzialnością — Class I — MDR — listed in EUDAMED
Similar devices
Also classified as Ankle/foot orthosis.
- Strp Only, Long, SA Wide Fl 12.5 E Stop — Becker Orthopedic Appliance Company · Class I
- Strp, SFL, 8.25in C Stop , AJT, SA, B — Becker Orthopedic Appliance Company · Class I
- Strp, Spl, WF Cal Pl, AJT, SA B, Free Mot LM/RL — Becker Orthopedic Appliance Company · Class I
- ALIMED ANKLE BRACE ALL AIR TUBE — AliMed, LLC · Class I
- Ankle support with 2 straps - Neoprene - onesize — ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. · Class I
- 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 | 590771338O001C3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Armedical Spółka Z Ograniczoną Odpowiedzialnością
- EUDAMED SRN
- PL-MF-000036062
Sources (4)
- EUDAMED 5cffcf55-2f52-4407-9a3e-a68002b32fc4 61 fields · synced Oct 8, 2026
- EUDAMED 011bcfbe-7ea8-40a7-b365-bdfafb41e731 61 fields · synced May 16, 2026
- EUDAMED 76d11a99-8217-434d-9115-9e52a720cc71 61 fields · synced May 18, 2026
- EUDAMED bea2859a-229b-46c7-9877-7f7bf0367e83 61 fields · synced May 19, 2026