ProWellness Health Solutions Oy
Finland Last updated 21 Oct 2026
- Devices
- 4
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Bolus Calculator Ref D-FI-MF-000009237-12Q
Balansio Ref D-FI-MF-000009237-32U
A1c estimator Ref D-FI-MF-000009237-42W
ProWellness Chronic Diseases Management System Ref D-FI-MF-000009237-22S
What ProWellness Health Solutions Oy makes
ProWellness Health Solutions Oy manufactures software-based medical devices for diabetes management, including a bolus calculator for insulin dosing, a continuous glucose monitoring system called Balansio, and an A1c estimator for long-term blood sugar trend analysis. The company also provides a comprehensive chronic diseases management system designed to support patient monitoring and care coordination for individuals with diabetes or related conditions.
The company’s portfolio includes devices classified as Class I and Class IIb under EU regulations, with all relevant products registered in the EU’s eudamed database. ProWellness Health Solutions Oy is based in Finland and adheres to EU medical device compliance requirements for software and diagnostic tools.
Frequently asked questions
How many devices does ProWellness Health Solutions Oy have in the registry?
The registry currently lists 4 devices for ProWellness Health Solutions Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list ProWellness Health Solutions Oy's devices?
Among its 4 most recently registered devices, ProWellness Health Solutions Oy has devices listed in EUDAMED (4 devices).
What risk classes do ProWellness Health Solutions Oy's devices fall under?
Among its 4 most recently registered devices, the classes recorded for ProWellness Health Solutions Oy's devices are Class I and Class IIb. Each device page shows its own class and authorisation.
What are the newest devices from ProWellness Health Solutions Oy in the registry?
The most recently registered devices listed for ProWellness Health Solutions Oy include Bolus Calculator, Balansio, A1c estimator and ProWellness Chronic Diseases Management System.
Information
- Address
- 1 D, Hoitajanrinne, Oulu, Finland
- Website
- www.prowellness.com
- [email protected]
- PRRC contact
- Mika Sipila
- EUDAMED SRN
- FI-MF-000009237