← Back to catalogue
Fiber Optic Cables and Accessories (Adapters)
EUDAMEDFDA UDIClass I (EU MDR)
Ref Please see field "Additional product description". Maximum entry length of 120 is not sufficient.
Identity
- Trade Name
- Sunoptic Technologies FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- Fiber Optic Cables and Accessories (Adapters) EUDAMEDfiberoptic cables FDA UDI
- Model / Reference
- Please see field "Additional product description". Maximum entry length of 120 is not sufficient. EUDAMEDFiberoptic Cables FDA UDI
- Description
- fiberoptic cables FDA UDI
Identifiers
- Primary DI / UDI-DI
- M678FOC0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M678FOCYV EUDAMED
- FDA Product Code
- FST FDA UDIEQH FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI874.4350 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Fiber Optic Cables and Accessories (Adapters) by Sunoptic Technologies — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++M678FOCYV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sunoptic Technologies
- EUDAMED SRN
- US-MF-000006235
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (2)
- EUDAMED c45fd083-408d-4205-98f0-83453e772041 61 fields · synced Aug 4, 2026
- FDA UDI ec8f4006-db2a-4cc3-847c-88c317fd9732 34 fields · synced May 30, 2026