Medisono END-VYS HDL-35E Light Source
Medisono END-VYS HDL-35E Light Source (MES01005) is a Class II device made by Medisono, LLC, cleared under FDA 510(k) K211882 on 1 Apr 2022 and listed in FDA GUDID since 17 Nov 2023 (UDI-DI B369MES01005), 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 | NumberB369MES01005 | Date17 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211882 | Date1 Apr 2022 | StatusActive |
Official records
- FDA 510(k) database K211882
Across registries
- FDA 510(k) K211882 decided 1 Apr 2022 Active
- FDA GUDID UDI-DI B369MES01005 listed 17 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K211882
- Listed FDA GUDID B369MES01005
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medisono
- Generic name
- Endoscopic light source unit, line-powered
- Model / Ref / Catalog
- Medisono END-VYS HDL-35E Light Source, MES01005
- Primary DI / UDI-DI
- B369MES01005
- 510(k) Number
- FDA product code
- FDS
- GMDN term
- Endoscopic light source unit, line-powered
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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