Identity
- Trade Name
- OP-HL15 LED EUDAMED
- Device Name
- Headlight EUDAMED
- Model / Reference
- 30573645 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436041580355 EUDAMED
- Basic UDI-DI
- 84360415807263N EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES 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
Op-Hl15 Led by Optomic España S.a — Class I — MDR — listed in EUDAMED — 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 | 84360415807263N | Class I | Active |
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Manufacturer
- Manufacturer
- Optomic España S.a
- EUDAMED SRN
- ES-MF-000003235
Sources (1)
- EUDAMED 57cb5f64-ac5e-4d33-bff5-b99b84f5dfcb 61 fields · synced Jun 18, 2026