Identity
- Trade Name
- DEDILES CON TEJIDO T.M ; LINED DIGITAL CUP EUDAMED
- Device Name
- Orthoses, foot (including insoles and inserts) EUDAMED
- Model / Reference
- GL-105#M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435025947115 EUDAMED
- Basic UDI-DI
- 84350259ORL20420PS EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- Models / Variants
- Dediles Con Tejido T.m EUDAMEDLined Digital Cup 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
Dediles Con Tejido T.m +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 | 84350259ORL20420PS | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED b00a4185-d6c4-4f74-9f6f-752b56623a83 61 fields · synced Aug 4, 2026