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Fundus Camera
EUDAMEDClass I (EU MDR)
Ref N/AModel Kestrel 300Model RetiCam 3100 Plus
Identity
- Device Name
- Fundus Camera EUDAMED
- Model / Reference
- Kestrel 300 EUDAMEDN/A EUDAMEDRetiCam 3100 Plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973009600110 EUDAMED06973009600189 EUDAMED
- Basic UDI-DI
- 697300960011GD EUDAMED697300960018GT 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 — 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 | 697300960011GD | 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 0bf41215-5c62-4515-b55c-66f7a2b5b268 61 fields · synced Jul 25, 2026
- EUDAMED 6536d6b3-00c6-4515-92b6-4b8eaee7729c 61 fields · synced May 19, 2026