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Classys

Also registered as CLASSYS INC

South KoreaFDA applicant, unverified FDA FEI 3010363436

Classys is a medical device manufacturer, with 1 device listed in FDA 510(k) (FDA Class II) as of 13 Nov 2026.

Devices
1
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 1
Device classes
  • FDA Class II 1
Sites and related companies
Identifiers
  • FDA FEI 3010363436

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment
Authorised rep.
Medical Technology Promedt Consulting GmbHDE

Catalogue1

Newest first, rows 1-1 of 1

  • Volnewmer™ Ref K253504

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

Company details

FDA FEI number
3010363436
Address
9F, 25, Deokcheon-ro 152beon-gil, Anyang-si Gyeonggi

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • CLASSYS Inc. KR

Frequently asked questions

How many devices does CLASSYS have in the registry?

The registry currently lists 1 device for CLASSYS. Devices recorded under merged duplicate company entries are counted once.

Which registries list CLASSYS's devices?

Among its 1 most recently registered device, CLASSYS has devices listed in FDA 510(k) (1 device).

What risk classes do CLASSYS's devices fall under?

Among its 1 most recently registered device, the classes recorded for CLASSYS's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from CLASSYS in the registry?

The most recently registered devices listed for CLASSYS include Volnewmer™.

Which FDA establishments are linked to CLASSYS?

1 FDA establishment is linked to CLASSYS in the registry; they are listed on the company page.

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