Identity
- Trade Name
- Direct Ophthalmoscope EUDAMED
- Device Name
- Direct Ophthalmoscope EUDAMED
- Model / Reference
- YZ11D EUDAMED336289362401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951090800428 EUDAMED
- Basic UDI-DI
- 69510908YZ116SV EUDAMED
- Direct Marketing DI
- 06951090800428 EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Direct Ophthalmoscope by 66 Vision Tech Co., Ltd. — 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 | 69510908YZ116SV | Class I | Active |
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Manufacturer
- Manufacturer
- 66 Vision Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000030050
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 85f590d9-c23d-4d6e-a188-393c75b7ad03 61 fields · synced Aug 3, 2026