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Gynius AB

SwedenFDA applicant, unverified

Gynius AB is a medical device manufacturer, with 2 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 15 Nov 2026.

Devices
2

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA 510(k) 1
  • FDA GUDID 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 2
Identifiers
  • DUNS 777393922

Catalogue2

Newest first, rows 1-2 of 2

  • Gynius V1

    Listed Registry: GUDID Class:II

  • The Gynocular Ref K132423

    Active Regimes: 510(k) Registry: 510(k) Class:II

Company details

DUNS number
777393922
Phone
+468303035

Frequently asked questions

How many devices does Gynius AB have in the registry?

The registry currently lists 2 devices for Gynius AB. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gynius AB's devices?

Among its 2 most recently registered devices, Gynius AB has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Gynius AB's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Gynius AB's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Gynius AB in the registry?

The most recently registered devices listed for Gynius AB include Gynius V1 and THE GYNOCULAR.

Generated automatically from registry data and not verified by a human reviewer.