Identity
- Trade Name
- SYSEYE FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- Fundus Camera EUDAMED
- Model / Reference
- RetiCam 3100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973009600011 EUDAMEDFDA UDI
- Basic UDI-DI
- 697300960001GA EUDAMED
- 510(k) Number
- K190954 FDA UDI
- FDA Product Code
- HKI FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1120 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Fundus Camera by Chongqing Bio Newvision Medical Equipment Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697300960001GA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 8ba753b3-7af3-4a8f-935a-f077ac0cb0e2 61 fields · synced Jul 23, 2026
- FDA UDI f478a9ca-a230-48d3-a6a4-ad8d8cc7dc5b 33 fields · synced May 29, 2026