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Combinostics Oy

Active in EUDAMED
Also registered as COMBINOSTICS

Finlandfrom SRN EUDAMED SRN FI-MF-000011968

Devices
5
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 2 in force. 1 certificate has expired.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates

What Combinostics Oy makes

Combinostics Oy manufactures imaging analysis software tools designed for advanced medical imaging modalities, including cNeuro cMRI for MRI-based neuroimaging, cNeuro cPET for PET scan analysis, cNeuro cDAT for dopamine transporter imaging, and cNeuro cDSI for diffusion spectroscopy imaging. These tools are intended to assist in neurological diagnostics and research by processing and interpreting complex imaging data.

The company’s portfolio includes devices classified under EU Class II and Class IIa, with registrations in the EU’s EUDAMED database and FDA’s 510(k) clearance system. Combinostics Oy is based in Finland and adheres to relevant regulatory frameworks for these imaging-related software solutions.

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

Catalogue5

Newest first, rows 1-5 of 5

  • cNeuro cMRI

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • cNeuro cPET Ref K231576

    Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II

  • cNeuro cDAT

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIa

  • cNeuro cMRI

    Active Regimes: 510(k) CE MDR, withdrawn CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • cNeuro cDSI

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

Company details

EUDAMED SRN
FI-MF-000011968
DUNS number
368347547
EU VAT number
FI26316847
EUDAMED status
Active
EUDAMED registered name
Combinostics Oy
EUDAMED abbreviated name
Combinostics
Registered address
24, Hatanpään valtatie, 33100, Tampere, Finland
Phone
+358400139013
PRRC contact
Lisa Warnroth(public in EUDAMED)

EUDAMED certificates2

2 certificates1 valid, 1 expiredMDR 2next expiry 19 Feb 2030

EUDAMED certificates (2)

SGS FIMKO OY 0598 2 certificates

  • FI22/871878 Active Supplemented

    Quality management system EU MDR

    Issued
    10 Oct 2025
    Expires
    19 Feb 2030
    Valid from
    11 Oct 2025
    Reason
    Change approved
  • FI22/871878 Expired

    Quality management system EU MDR

    Issued
    3 May 2024
    Expires
    7 May 2025
    Reason
    Change approved

Frequently asked questions

How many devices does Combinostics Oy have in the registry?

The registry currently lists 5 devices for Combinostics Oy. Devices recorded under merged duplicate company entries are counted once.

Which registries list Combinostics Oy's devices?

Among its 5 most recently registered devices, Combinostics Oy has devices listed in EUDAMED (5 devices), FDA 510(k) (1 device) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Combinostics Oy's devices fall under?

Among its 5 most recently registered devices, the classes recorded for Combinostics Oy's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Combinostics Oy?

EUDAMED lists 2 certificates for Combinostics Oy (quality management system) under MDR. The most recent was issued on 10 Oct 2025.

What are the newest devices from Combinostics Oy in the registry?

The most recently registered devices listed for Combinostics Oy include cNeuro cMRI, cNeuro cPET, cNeuro cDAT and cNeuro cDSI.

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