Identity
- Device Name
- Fundus Camera EUDAMED
- Model / Reference
- VX625 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973009600318 EUDAMED
- Basic UDI-DI
- 697300960031GK EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Fundus Camera by Chongqing Bio Newvision Medical Equipment Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190954 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697300960031GK | Class I | Active |
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Manufacturer
- Manufacturer
- Chongqing Bio NewVision Medical Equipment Ltd.
- EUDAMED SRN
- CN-MF-000026465
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED ad756bb6-1628-4358-9aba-b092ab119b17 61 fields · synced Jun 18, 2026
- FDA 510(k) K190954 1 fields · synced May 18, 2026