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EVA System 2

by Mobileodt, Ltd.

EVA System 2 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 16 May 2017 (UDI-DI 17290016976004), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K161871

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17290016976004 UDI-DI Date16 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161871 Date19 Dec 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161871 decided 19 Dec 2016 Active
  • FDA GUDID UDI-DI 17290016976004 listed 16 May 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161871
  2. Listed FDA GUDID 17290016976004

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EVA System
Generic name
Colposcope
Model / reference
2
Primary DI / UDI-DI
17290016976004
510(k) Number
FDA product code
HEX
GMDN term
Colposcope
Device class
Class II
Regulation number
884.1630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Colposcope

Cleared under the same submission (K161871)

Similar devices

Other devices filed under FDA product code HEX (Colposcope (And Colpomicroscope)).

Other devices from Mobileodt, Ltd.

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)