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Plantilla De Silicona Forrada +1 more model
EUDAMEDClass I (EU MDR)
Ref ACP936#4
Identity
- Trade Name
- PLANTILLA DE SILICONA FORRADA ; LINED SILICONE INSOLE EUDAMED
- Device Name
- Podología (Plantillas) EUDAMED
- Model / Reference
- ACP936#4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491818698 EUDAMED
- Basic UDI-DI
- 84350259ORL20418Q7 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- Models / Variants
- Plantilla De Silicona Forrada EUDAMEDLined Silicone 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 De Silicona Forrada +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 | 84350259ORL20418Q7 | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED 46717c0b-05a9-44c9-9ab8-5d715ee016d4 61 fields · synced Jul 15, 2026