FloNavi Light source
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- FloNavi Light source EUDAMEDFDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- Light source EUDAMED
- Model / Reference
- OPTO-LED2100,71-180-30 NIR EUDAMEDOPTO-LED2100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973031299962 EUDAMEDFDA UDI
- Basic UDI-DI
- 697303129LED00001CY EUDAMED
- 510(k) Number
- K221861 FDA UDI
- FDA Product Code
- GCJ FDA UDIIZI FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Endoscopic light source unit, line-powered
FloNavi Light source by Guangdong Optomedic Technologies, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697303129LED00001CY | 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 438e0663-9252-4eb1-86c9-76cfbd3c362b 61 fields · synced Jul 9, 2026
- FDA UDI 8cc34fb0-55a0-4663-97d8-d360c19f8389 33 fields · synced May 30, 2026