Identity
- Device Name
- Fundus Camera EUDAMED
- Model / Reference
- Kestrel 3100m EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973009600028 EUDAMED
- Basic UDI-DI
- 697300960002GC EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER 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
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 | 697300960002GC | 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 (1)
- EUDAMED f7682892-b571-429f-9642-9c26c746e1b3 61 fields · synced Jun 18, 2026