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FloNavi Open Field Fluorescence Imaging Head
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref OPTO-CHD3100EModel OPTO-CHD3100E，71-066-55 NIR
Identity
- Trade Name
- FloNavi Open Field Fluorescence Imaging Head EUDAMEDOpen Field Fluorescence Imaging Head FDA UDI
- Generic Name
- Surgical video camera FDA UDI
- Device Name
- Open Field Fluorescence Imaging Head EUDAMED
- Model / Reference
- OPTO-CHD3100E，71-066-55 NIR EUDAMEDOPTO-CHD3100E EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973031299986 EUDAMEDFDA UDI
- Basic UDI-DI
- 697303129CHD0000198 EUDAMED
- 510(k) Number
- K230407 FDA UDI
- FDA Product Code
- OWN FDA UDIIZI FDA UDIGCJ FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Surgical video camera FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI892.1600 FDA UDI
- Market of Registration
- Ireland 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
FloNavi Open Field Fluorescence Imaging Head by Guangdong Optomedic Technologies, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697303129CHD0000198 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Guangdong Optomedic Technologies, Inc.
- EUDAMED SRN
- CN-MF-000011588
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED b5063cff-12e7-4222-ac78-8fdde41d90e4 61 fields · synced Jul 9, 2026
- FDA UDI 854bccf9-0c86-4801-b8ec-1f327265af2d 33 fields · synced May 30, 2026