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Gynius V1

by Gynius AB

Gynius V1 (GYN-0001) is a colposcope (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Gynius AB, listed in FDA GUDID since 22 Sep 2016 (UDI-DI 07300009046461), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07300009046461 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Gynius
Generic name
Colposcope
Model / Ref / Catalog
V1, GYN-0001
Primary DI / UDI-DI
07300009046461
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

Similar devices

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

Other devices from Gynius AB

  • The Gynocular

    Class II

Properties

  • Convenience kit
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)