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Ophthalmology Images Processing System
EUDAMEDClass I (EU MDR)
Ref ZZ-EYE-DavinciAI
Identity
- Device Name
- Ophthalmology Images Processing System EUDAMED
- Model / Reference
- ZZ-EYE-DavinciAI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975087570040 EUDAMED
- Basic UDI-DI
- 6975087571004DV EUDAMED
- Direct Marketing DI
- 06975087570040 EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software 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
Ophthalmology Images Processing System by Beijing Zhenhealth Technology 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 | 6975087571004DV | Class I | Active |
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Manufacturer
- Manufacturer
- Beijing Zhenhealth Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000020398
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED cb688736-0cad-4fa3-948a-f30a1ab981f4 61 fields · synced Jun 18, 2026