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Fulcrum

Active in EUDAMED

Francefrom SRN EUDAMED SRN FR-MF-000015624

Devices
8
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What Fulcrum makes

Fulcrum manufactures fixed orthodontic appliances known as Orthèse Herbst Amoric (OHA), designed for dental alignment and jaw correction in orthodontic treatment. These devices are used to address skeletal discrepancies and guide tooth movement during orthodontic therapy.

The company’s products fall under EU Class I medical devices and are listed in the EUDAMED database. Fulcrum operates from France, adhering to European regulatory requirements for Class I orthodontic appliances.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8

Newest first, rows 1-8 of 8

Company details

EUDAMED SRN
FR-MF-000015624
EU VAT number
FR69393019575
EUDAMED status
Active since 2016
EUDAMED registered name
Fulcrum
Registered address
300, rue Geiler de Kaysersberg, 67400, Illkirch Graffestaden, France
Phone
+33 (0)677067508
PRRC contact
Marc MAYER(public in EUDAMED)

From the company website

Read 18 Sep 2026

Fulcrum is a company specialized in the treatment of orthodontics and respiratory sleep disorders.

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does Fulcrum have in the registry?

The registry currently lists 8 devices for Fulcrum. Devices recorded under merged duplicate company entries are counted once.

Which registries list Fulcrum's devices?

Among its 8 most recently registered devices, Fulcrum has devices listed in EUDAMED (8 devices).

What risk classes do Fulcrum's devices fall under?

Among its 8 most recently registered devices, the classes recorded for Fulcrum's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Fulcrum in the registry?

The most recently registered devices listed for Fulcrum include OHA (Orthèse Herbst Amoric) and OHA Orthèse Herbst Amoric S.

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