Identity
- Trade Name
- OPTIMA EUDAMED
- Device Name
- Optima EUDAMED
- Model / Reference
- TO-LIGHTM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054794757420 EUDAMED
- Basic UDI-DI
- 805715830OPTIMALZ EUDAMED
- Direct Marketing DI
- 08054794757420 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Category: Ankle/foot orthosis
Optima by Optima Molliter Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 805715830OPTIMALZ | Class I | Active |
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Manufacturer
- Manufacturer
- Optima Molliter Srl
- EUDAMED SRN
- IT-MF-000022195
Sources (1)
- EUDAMED 3bc3dca2-0b8a-4313-8070-5145269742f3 61 fields · synced Oct 9, 2026