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Sign in to claim this brandLIMITED LIABILITY COMPANY RESEARCH AND PRODUCTION ENTERPRISE "SAMOZDRAV"
Russia·RU-MF-000034190
Last updated September 18, 2026
About
EU Authorised Representative (MDR/IVDR Article 11) and PRRC services for medical device and IVD manufacturers established outside the EU.
From the manufacturer's own website. Source
What LIMITED LIABILITY COMPANY RESEARCH AND PRODUCTION ENTERPRISE "SAMOZDRAV" makes
The manufacturer produces respiratory training devices under the Samozdrav brand, including the Samozdrav STANDARD, Samozdrav COMFORT, and Samozdrav COSMICHEALTH FOR KIDS models. These are non-invasive breathing exercisers designed for respiratory muscle training and lung function support.
All listed devices are classified as Class I under the EU regulatory framework and are registered in the Eudamed database. The company is based in the Russian Federation (RU) and operates as a Limited Liability Company.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of medical devices does LIMITED LIABILITY COMPANY RESEARCH AND PRODUCTION ENTERPRISE "SAMOZDRAV" produce?
The company produces respiratory training devices under the Samozdrav brand, specifically the Samozdrav STANDARD, Samozdrav COMFORT, and Samozdrav COSMICHEALTH FOR KIDS models. These are non-invasive breathing exercisers designed for respiratory muscle training and lung function support, as stated in the provided summary.
Where is LIMITED LIABILITY COMPANY RESEARCH AND PRODUCTION ENTERPRISE "SAMOZDRAV" based?
The company is based in the Russian Federation, as indicated by the country code RU in the device data and confirmed in the summary which states it operates as a Limited Liability Company in the Russian Federation.
In which regulatory registry are the devices of LIMITED LIABILITY COMPANY RESEARCH AND PRODUCTION ENTERPRISE "SAMOZDRAV" listed?
The devices are listed in the Eudamed database, as explicitly stated in the device data under LISTED IN and reiterated in the summary which confirms all listed devices are registered in the Eudamed database.
How are the medical devices produced by LIMITED LIABILITY COMPANY RESEARCH AND PRODUCTION ENTERPRISE "SAMOZDRAV" classified under the EU regulatory framework?
All listed devices are classified as Class I under the EU regulatory framework, as directly stated in the device data under DEVICE CLASSES and confirmed in the summary which notes that all listed devices are classified as Class I.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Russia
- Address
- 18, Passage 9 May, Samara, Russia
- Website
- www.getear.eu
- —
- —
- [email protected]
- Phone
- +420608049029 (from company website)
- PRRC Contact
- German Roters
- EUDAMED SRN
- RU-MF-000034190
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Samozdrav STANDARD | C01 | EUDAMED | Class I | Active |
| Samozdrav COMFORT | K01 | EUDAMED | Class I | Active |
| Samozdrav COSMICHEALTH FOR KIDS | D01 | EUDAMED | Class I | Active |
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