Identity
- Trade Name
- PLANTILLA SILICONA ; SILICONE INSOLE EUDAMED
- Device Name
- Podología (Plantillas) EUDAMED
- Model / Reference
- ACP935#0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491818599 EUDAMED
- Basic UDI-DI
- 84350259ORL20418Q7 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- Models / Variants
- Plantilla Silicona EUDAMEDSilicone Insole 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
PLANTILLA SILICONA - Silicone Insole 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 | 84350259ORL20418Q7 | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED cc39f9f4-be18-4a1c-8f83-e4594f939a83 61 fields · synced Jul 9, 2026