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Air Walker Alto Articulado T.3 M: <=45 +1 more model
EUDAMEDClass I (EU MDR)
Ref EST-083#3
Identity
- Trade Name
- AIR WALKER ALTO ARTICULADO T.3 M: <=45 ; ROM AIR WALKER EUDAMED
- Device Name
- Ortesis de tobillo - Walkers EUDAMED
- Model / Reference
- EST-083#3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435025920477 EUDAMED
- Basic UDI-DI
- 84350259ORL20408Q4 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
- Models / Variants
- Rom Air Walker EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Air Walker Alto Articulado T.3 M: <=45 +1 more model by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 2 models — 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 | 84350259ORL20408Q4 | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED bfa76c77-acab-47fa-afc2-4c9f086c4fe1 61 fields · synced Jul 12, 2026