Identity
- Trade Name
- Fiber Optic + Ophthalmoscope EUDAMED
- Device Name
- Fiber Optic + Ophthalmoscope Sets with 02 Extra LED LightsPacked In Eva Packaging In Different 04 Colors EUDAMED
- Model / Reference
- 786-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004816048 EUDAMED
- Basic UDI-DI
- 8964004816786-05QX EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Fiber Optic + Ophthalmoscope by Surgical Appliances — 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 | 8964004816786-05QX | Class I | Active |
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Manufacturer
- Manufacturer
- Surgical Appliances
- EUDAMED SRN
- PK-MF-000042541
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 1306d08d-1708-4d6c-960c-746fe4abb90b 61 fields · synced Jul 10, 2026