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PLANTILLAS SIL. EXTRAFINA FORRADA - Plantillas Sil. Extrafina Forrada
EUDAMEDClass I (EU MDR)
Ref ACP934#4
Identity
- Trade Name
- PLANTILLAS SIL. EXTRAFINA FORRADA ; EXTRAFINE LINED SILICONE INNER SOLE EUDAMED
- Device Name
- Podología (Plantillas) EUDAMED
- Model / Reference
- ACP934#4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491818582 EUDAMED
- Basic UDI-DI
- 84350259ORL20418Q7 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- Models / Variants
- Plantillas Sil. Extrafina Forrada 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
PLANTILLAS SIL. EXTRAFINA FORRADA - Plantillas Sil. Extrafina Forrada by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 2 models
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 efb07d00-f855-4f5c-98ae-881db9ce3f1d 61 fields · synced Oct 7, 2026