← Back to catalogue
FloNavi Endoscopic Fluorescence Camera Head
EUDAMEDFDA UDIClass I (EU MDR)
Ref OPTO-CHD2100Model OPTO-CHD2100,71-066-10 NIR
Identity
- Trade Name
- FloNavi Endoscopic Fluorescence Camera Head EUDAMEDFloNavi Camera Head FDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- Camera Head EUDAMED
- Model / Reference
- OPTO-CHD2100,71-066-10 NIR EUDAMEDOPTO-CHD2100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973031299825 EUDAMEDFDA UDI
- Basic UDI-DI
- 697303129CHD000079L EUDAMED
- Direct Marketing DI
- 06973031299825 EUDAMED
- 510(k) Number
- K221861 FDA UDI
- FDA Product Code
- GCJ FDA UDIIZI FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class I 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
High-level Disinfectant FDA UDI
FloNavi Endoscopic Fluorescence Camera Head by Guangdong Optomedic Technologies, Inc. — Class I — 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 | 697303129CHD000079L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangdong Optomedic Technologies, Inc.
- EUDAMED SRN
- CN-MF-000011588
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED a057f8d4-3b78-4ccf-b292-817b8c9c630a 61 fields · synced Jul 25, 2026
- FDA UDI 111a8278-5f5c-484f-9e81-ae2f6fc5ecbd 33 fields · synced May 30, 2026