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OneTwo Analytics AB

Active in EUDAMED

Swedenfrom SRN EUDAMED FDA SRN SE-MF-000049462 FEI 3028170577

Devices
3
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What OneTwo Analytics AB makes

OneTwo Analytics AB develops software-based diabetes analytics platforms, including OneTwo Insights for healthcare professionals and OneTwo Diabetes for individuals managing diabetes. The PRIO system appears to be a related tool for diabetes monitoring or intervention support, leveraging AI-driven data analysis to generate automated insights and decision aids.

The company’s products are classified as Class I and Class IIa medical devices and are registered in the EUDAMED database. OneTwo Analytics AB is based in Sweden.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • OneTwo Insights Ref 07350158330041

    Withdrawn Regimes: CE MDR, withdrawn CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • OneTwo Diabetes Ref 07350158330065

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Prio Ref 07350158330058

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Company details

EUDAMED SRN
SE-MF-000049462
FDA FEI number
3028170577
EU VAT number
SE559200971501
EUDAMED status
Active
EUDAMED registered name
OneTwo Analytics AB
Registered address
84, Kungsgatan, 11227, Stockholm, Sweden
PRRC contact
Jakob Dumky(public in EUDAMED)

From the company website

Read 18 Oct 2026

OneTwo Analytics is a diabetes analytics platform that uses AI and diabetes data to deliver automated insights and decision support for healthcare professionals and people living with diabetes.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does OneTwo Analytics AB have in the registry?

The registry currently lists 3 devices for OneTwo Analytics AB. Devices recorded under merged duplicate company entries are counted once.

Which registries list OneTwo Analytics AB's devices?

Among its 3 most recently registered devices, OneTwo Analytics AB has devices listed in EUDAMED (3 devices).

What risk classes do OneTwo Analytics AB's devices fall under?

Among its 3 most recently registered devices, the classes recorded for OneTwo Analytics AB's devices are Class I and Class IIa. Each device page shows its own class and authorisation.

What are the newest devices from OneTwo Analytics AB in the registry?

The most recently registered devices listed for OneTwo Analytics AB include OneTwo Insights, OneTwo Diabetes and PRIO.

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