Identity
- Model / Reference
- Fiberoptic Light Guides EUDAMEDOP965 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250480102473 EUDAMED
- Basic UDI-DI
- 42504801FOLIGHTGUIDESHV EUDAMED
- Direct Marketing DI
- 04250480102473 EUDAMED
- EMDN Code
- Z12020480 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES 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
Op965 by SCHÖLLY FIBEROPTIC GmbH — 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 | 42504801FOLIGHTGUIDESHV | Class I | Active |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (1)
- EUDAMED 3088f382-0600-453f-9f15-25e345f1dace 61 fields · synced Jun 18, 2026