Identity
- Model / Reference
- NIR Light Sources EUDAMEDOP961 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250480104507 EUDAMED
- Basic UDI-DI
- 42504801NIRLIGHTSOURCESQK EUDAMED
- Direct Marketing DI
- 04250480104507 EUDAMED
- EMDN Code
- Z12029007 INFRA–RED SURGICAL ILLUMINATORS EUDAMED
Classification
- Device Class
- Class IIa 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
Op961 by SCHÖLLY FIBEROPTIC GmbH — Class IIa — 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 | 42504801NIRLIGHTSOURCESQK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (1)
- EUDAMED d9083124-58df-4deb-a480-d65dafaceb96 61 fields · synced Jul 17, 2026