Identity
- Trade Name
- WhtNavi EUDAMEDWhtNavi Light Source FDA UDI
- Generic Name
- Endoscopic video image processing/light source system FDA UDI
- Device Name
- Light Source EUDAMED
- Model / Reference
- OPTO-LED104K EUDAMEDFDA UDI4020015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973031299894 EUDAMEDFDA UDI
- Basic UDI-DI
- 697303129LED00003D4 EUDAMED
- FDA Product Code
- NTN FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic video image processing/light source system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic light source unit, line-powered
WhtNavi by Guangdong Optomedic Technologies, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 697303129LED00003D4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 00f99648-6f7c-4844-9f76-a8f43e4d4aed 61 fields · synced Jun 19, 2026
- FDA UDI 78b9ef17-ab07-4210-a27f-156927351e6e 32 fields · synced May 30, 2026