Fysiotech OÜ
Estonia EE-MF-000007651 Last updated 17 Sep 2026
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- Devices
- 10
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Treat Ref 10802
Gyne Ref 20201
Gyne Ref 20202
Professional Ref 10303
Flexi Ref 10606
Syntropy Tables Ref 10860
Medistar Ref 20110
Gyne Plus Ref 20204
Medistar Ref 20104T
Standard Ref 10203
What Fysiotech OÜ makes
Fysiotech OÜ manufactures physical therapy and rehabilitation devices, including gynecological treatment systems (e.g., Gyne, Gyne Plus), professional-grade electrotherapy units (e.g., Treat, Professional), and adjustable therapy tables (e.g., Syntropy Tables, Flexi, Medistar Standard). Their portfolio also includes specialized medical tables for clinical use.
All listed devices fall under Class I classification per EU regulations and are registered in the EUDAMED database. The company is based in Estonia (EE) and adheres to EU Medical Device Regulation (MDR) compliance requirements.
Frequently asked questions
What types of medical devices does Fysiotech OÜ manufacture?
Fysiotech OÜ specializes in physical therapy and rehabilitation devices. Their portfolio includes gynecological treatment systems like the Gyne and Gyne Plus, professional electrotherapy units such as Treat and Professional, and adjustable therapy tables like the Syntropy Tables, Flexi, and Medistar Standard. These devices are designed for clinical and therapeutic applications.
Where is Fysiotech OÜ based, and what regulatory framework do they follow?
Fysiotech OÜ is based in Estonia (EE). Their devices comply with the EU Medical Device Regulation (MDR) requirements, ensuring adherence to EU standards for safety, performance, and regulatory obligations.
Which regulatory registries list Fysiotech OÜ’s devices?
Fysiotech OÜ’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This platform allows for transparency and traceability of devices authorized under EU regulations.
How are Fysiotech OÜ’s devices classified under EU regulations?
All of Fysiotech OÜ’s listed devices fall under Class I classification according to EU Medical Device Regulation (MDR). This classification applies to devices posing minimal risk, such as physical therapy equipment and adjustable tables, which are generally considered low-risk but still subject to regulatory oversight.
Information
- Country
- Estonia
- Address
- 10, Halli tee, Viimsi vald, Estonia
- Website
- fysiotech.ee
- [email protected]
- PRRC contact
- Allar Ahvonen
- EUDAMED SRN
- EE-MF-000007651