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Orthosoft

Active in EUDAMED

Francefrom SRN EUDAMED FDA SRN FR-MF-000000216

Orthosoft is a medical device manufacturer based in France, with 27 devices listed in EUDAMED (EU Class I) as of 13 Nov 2026.

Devices
27
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 27
Device classes
  • EU Class I 27
Top EMDN categories
Identifiers
  • EUDAMED SRN FR-MF-000000216

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment

What Orthosoft makes

Orthosoft manufactures a range of customisable orthotic devices, including foot and ankle supports like the Manusoft Evolution, Episoft, and Valgusoft, as well as knee braces such as the Rhizorthese and Flexsoft. Additional products include immobilisation splints (e.g., Glensoft, Immosoft) and orthopaedic supports like the MP Soft, designed for clinical and post-operative use.

All listed devices fall under EU Class I medical device regulations and are registered in the EUDAMED database. The company is based in France and adheres to EU medical device compliance requirements for non-invasive orthopaedic aids.

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

Catalogue27

Newest first, rows 1-27 of 27

Search and filter all 27 devices
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  • Rhizorthese Ref RH12G

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Manusoft Evolution Ref ME11X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Episoft Ref EP11X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Valgusoft Ref VA12X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Worksoft Ref WO11X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Glensoft Ref GL11X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Rhizorthese Ref RH13G

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Immosoft Ref IM12D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Mp Soft Ref MP11X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Valgusoft Ref VA11X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Manusoft Evolution Ref ME12X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexsoft Ref FL11D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Glensoft Ref GL12X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexsoft Duo Ref FD11D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Rhizorthese Ref RH11G

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Rhizorthese Ref RH11D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Immosoft Ref IM11D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Rhizorthese Ref RH13D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Manusoft Ref MU12D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Cubisoft Ref CU11X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexsoft Ref FL12D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Immosoft Ref IM12G

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Canalsoft Ref CA11X

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Immosoft Ref IM11G

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Rhizorthese Ref RH12D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexsoft Duo Ref FD12G

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Manusoft Ref MU11G

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 1-27 of 27

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000000216
EU VAT number
FR46424936706
EUDAMED status
Active
EUDAMED registered name
ORTHOSOFT
Registered address
445, rue Helene Boucher, 34130, MAUGUIO, France
Phone
+33 6 11 37 07 30
PRRC contact
Laurent Davoine(public in EUDAMED)

FDA establishments1

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

  • Orthosoft Inc CA

From the company website

Read 18 Sep 2026

With 12 years of experience, Orthosoft designs, manufactures and produces reliable and high-quality orthotics.

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does ORTHOSOFT have in the registry?

The registry currently lists 27 devices for ORTHOSOFT. Devices recorded under merged duplicate company entries are counted once.

Which registries list ORTHOSOFT's devices?

Among its 27 most recently registered devices, ORTHOSOFT has devices listed in EUDAMED (27 devices).

What risk classes do ORTHOSOFT's devices fall under?

Among its 27 most recently registered devices, the classes recorded for ORTHOSOFT's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from ORTHOSOFT in the registry?

The most recently registered devices listed for ORTHOSOFT include RHIZORTHESE, MANUSOFT EVOLUTION, EPISOFT and VALGUSOFT.

Which FDA establishments are linked to ORTHOSOFT?

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

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