Teligen 286003210
Teligen 286003210 is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K213978 on 18 Oct 2022 and listed in FDA GUDID since 9 Nov 2022 (UDI-DI 10705034560526), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10705034560526 | Date9 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213978 | Date18 Oct 2022 | StatusActive |
Official records
- AccessGUDID record 10705034560526
- FDA 510(k) database K213978
Across registries
- FDA 510(k) K213978 decided 18 Oct 2022 Active
- FDA GUDID UDI-DI 10705034560526 listed 9 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K213978
- Listed FDA GUDID 10705034560526
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Teligen
- Generic name
- Endoscopic video image processing/light source system
- Model / Ref / Catalog
- 286003210
- Primary DI / UDI-DI
- 10705034560526
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Endoscopic video image processing/light source system
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Endoscopic video image processing/light source system.