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LOCALITE GmbH

Active in EUDAMED

Germanyfrom SRN EUDAMED FDA SRN DE-MF-000005419 FEI 3017603615

LOCALITE GmbH is a medical device manufacturer based in Germany, with 73 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I and IIa; FDA Class II) as of 15 Nov 2026.

Devices
73
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • EUDAMED 53
  • FDA GUDID 37
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • EU Class I 40
  • FDA Class II 21
  • EU Class IIa 12
Identifiers
  • EUDAMED SRN DE-MF-000005419
  • FDA FEI 3017603615
  • DUNS 315271657

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What LOCALITE GmbH makes

LOCALITE GmbH manufactures reusable device sterilization and disinfection containers alongside stereotactic neuronavigation and planning systems, such as the Localite TMS Navigator TS.

The company is based in Germany, and its product portfolio is regulated under Class I, Class II, and Class IIa classifications, with listings in EUDAMED, the FDA 510(k) database, and the FDA UDI registry.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue73

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
DE-MF-000005419
FDA FEI number
3017603615
DUNS number
315271657
EU VAT number
DE 213769662
EUDAMED status
Active
EUDAMED registered name
Localite GmbH
Registered address
1, Auguststraße, 53229, Bonn, Germany
PRRC contact
Arno Schmitgen(public in EUDAMED)

Frequently asked questions

How many devices does LOCALITE GmbH have in the registry?

The registry currently lists 73 devices for LOCALITE GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list LOCALITE GmbH's devices?

Among its 50 most recently registered devices, LOCALITE GmbH has devices listed in EUDAMED (30 devices), FDA 510(k) (1 device) and FDA GUDID (28 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do LOCALITE GmbH's devices fall under?

Among its 50 most recently registered devices, the classes recorded for LOCALITE GmbH's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from LOCALITE GmbH in the registry?

The most recently registered devices listed for LOCALITE GmbH include Localite TMS Navigator TS Adapterbox, Localite TMS Navigator TS System Cart, Localite TMS Navigator TS Adhesive Pads, square-cut (90 Pcs.) and Localite TMS Navigator TS Camera Cart for Vicra/Lyra.

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