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Dosisoft

Active in EUDAMED

Francefrom SRN EUDAMED FDA SRN FR-MF-000014706 FEI 3009302839

Dosisoft is a medical device manufacturer based in France, with 21 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIb and I) as of 13 Nov 2026.

Devices
21
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 13
  • EUDAMED 7
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 14
  • EU Class IIb 4
  • EU Class I 3
Identifiers
  • EUDAMED SRN FR-MF-000014706
  • FDA FEI 3009302839
  • DUNS 264815932

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment

What Dosisoft makes

Dosisoft develops software tools for radiation therapy planning and quality assurance, including dose calculation and verification systems like EPIgray, ISOgray, and MU2net. Their products also include treatment planning solutions such as PLANET Onco Dose and beam modeling tools like EPIbeam. ThinkQA Edition 2 supports phantom-based quality assurance for radiotherapy equipment.

The company’s portfolio includes devices classified as Class I and Class IIb under EU regulations, all of which are listed in the EUDAMED database. Dosisoft is based in France.

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

Catalogue21

Newest first, rows 1-21 of 21

Search and filter all 21 devices
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  • ThinkQA 3 3.0

    Active Regimes: 510(k) Registry: GUDID Class:II
  • ThinkQA 3 Ref K252937

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose 3.1.1

    Active Regimes: 510(k) Registry: GUDID Class:II
  • EPIgray 2.0.7

    Active Regimes: 510(k) Registry: GUDID Class:II
  • ThinkQA, EPIbeam 1.0.6

    Active Regimes: 510(k) Registry: GUDID Class:II
  • ThinkQA Edition 2 2.0.1

    Active Regimes: 510(k) Registry: GUDID Class:II
  • EPIgray 2.0.6

    Active Regimes: 510(k) Registry: GUDID Class:II
  • EPIgray 2.0.10

    Active Regimes: 510(k) Registry: GUDID Class:II
  • ThinkQA Edition 2 2.0.2

    Active Regimes: 510(k) Registry: GUDID Class:II
  • MU2net 2.1.1

    Active Regimes: CE MDD 510(k) Registry: GUDID Class:II
  • PLANET Onco Dose 3.2

    Active Regimes: 510(k) Registry: GUDID Class:II
  • ThinkQA, EPIbeam 1.0.2

    Active Regimes: 510(k) Registry: GUDID Class:II
  • ThinkQA, EPIbeam 1.0.4

    Active Regimes: CE MDD 510(k) Registry: GUDID Class:II
  • ThinkQA Edition 2 2.0.0

    Active Regimes: CE MDR 510(k) Registry: GUDID Class:II
  • Active Regimes: CE MDR Registry: EUDAMED Class:I
  • EPIgray Ref EP1001

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • ISOgray Ref IS1001

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • EPIbeam Ref EP1011

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • ThinkQA Edition 2

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:I
  • MU2net Ref MU1001

    Active Regimes: CE MDD 510(k) Registry: EUDAMED Class:I
  • PLANET Onco Dose Ref PL1100

    Active Regimes: CE MDR CE MDD 510(k) Registry: EUDAMED Class:IIb

Rows 1-21 of 21

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000014706
FDA FEI number
3009302839
DUNS number
264815932
EU VAT number
FR36443195433
EUDAMED status
Active
EUDAMED registered name
DOSISOFT
Registered address
45-47, Avenue Carnot, 94230, CACHAN, France
Phone
+33141242626
PRRC contact
Ahmad KHALIL(public in EUDAMED)

FDA establishments1

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

  • Dosisoft SA US

Frequently asked questions

How many devices does DOSISOFT have in the registry?

The registry currently lists 21 devices for DOSISOFT. Devices recorded under merged duplicate company entries are counted once.

Which registries list DOSISOFT's devices?

Among its 21 most recently registered devices, DOSISOFT has devices listed in EUDAMED (7 devices), FDA 510(k) (1 device) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do DOSISOFT's devices fall under?

Among its 21 most recently registered devices, the classes recorded for DOSISOFT's devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.

What are the newest devices from DOSISOFT in the registry?

The most recently registered devices listed for DOSISOFT include ThinkQA 3 3.0, ThinkQA 3, PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose 3.1.1 and EPIgray 2.0.7.

Which FDA establishments are linked to DOSISOFT?

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

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