Identity
- Trade Name
- Tobillo para ajustar talón ; ANKLE FOR HEEL ADJUSTMENT EUDAMED
- Device Name
- Adaptadores EUDAMED
- Model / Reference
- 2H08#NUNI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491813006 EUDAMED
- Basic UDI-DI
- 84350259ORL20509QB EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
- Models / Variants
- Tobillo para ajustar talón EUDAMEDANKLE FOR HEEL ADJUSTMENT 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
Tobillo para ajustar talón +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 | 84350259ORL20509QB | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED a53a879d-da00-4710-9cea-adc37c60b672 61 fields · synced Jun 19, 2026