Identity
- Device Name
- Bare Fiber EUDAMED
- Model / Reference
- 501201919 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049059515802 EUDAMED
- Basic UDI-DI
- 404905902N2 EUDAMED
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
Bare Fiber by CeramOptec 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 | 404905902N2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CeramOptec GmbH
- EUDAMED SRN
- DE-MF-000005607
Sources (1)
- EUDAMED 859eaf40-2e33-4537-938d-326e6bcb482d 61 fields · synced Jun 18, 2026