EVA System 3.0
EVA System 3.0 is a colposcope (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Mobileodt, Ltd., cleared under FDA 510(k) K161871 on 19 Dec 2016 and listed in FDA GUDID since 20 Nov 2018 (UDI-DI 17290016976011), 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 | Number17290016976011 | Date20 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161871 | Date19 Dec 2016 | StatusActive |
Official records
- AccessGUDID record 17290016976011
- FDA 510(k) database K161871
Across registries
- FDA 510(k) K161871 decided 19 Dec 2016 Active
- FDA GUDID UDI-DI 17290016976011 listed 20 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K161871
- Listed FDA GUDID 17290016976011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EVA System
- Generic name
- Colposcope
- Model / reference
- 3.0
- Primary DI / UDI-DI
- 17290016976011
- 510(k) Number
- FDA product code
- HEX
- GMDN term
- Colposcope
- Device class
- Class II
- Regulation number
- 884.1630
- GUDID distribution status
- In Commercial Distribution
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