Identity
- Trade Name
- OPTICLUX Hand 10-1 DL EUDAMED
- Device Name
- Hand-held examination light EUDAMED
- Model / Reference
- D16066000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640158711477 EUDAMED
- Basic UDI-DI
- 763079512SB EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
OPTICLUX Hand 10-1 DL by Derungs Licht AG — 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 | 763079512SB | Class I | Active |
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Manufacturer
- Manufacturer
- Derungs Licht AG
- EUDAMED SRN
- CH-MF-000015827
- Authorised Representative
- Derungs Medical GmbH DE-AR-000033841
Sources (1)
- EUDAMED ff30b6fb-5b09-489f-a424-fb2a550311d7 61 fields · synced Jul 22, 2026