Amara Therapeutics Ltd.
Ireland IE-MF-000045497 Last updated 21 Oct 2026
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- Devices
- 1
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
RiSolve Ref PDTxA001
About
Amara Therapeutics provide accessible and effective treatment for patients suffering from pelvic health conditions.
What Amara Therapeutics Ltd. makes
Amara Therapeutics Ltd. manufactures the RiSolve device, which appears to be designed for diagnostic or therapeutic use in pelvic health conditions, though specific clinical applications are not detailed.
The RiSolve device is classified as Class I under EU regulations and is registered in the EUDAMED database. The company is based in Ireland.
Frequently asked questions
What types of medical devices does Amara Therapeutics Ltd. manufacture?
Amara Therapeutics Ltd. manufactures the RiSolve device, which is intended for use in pelvic health conditions. While the exact clinical applications are not specified, the device appears to serve either diagnostic or therapeutic purposes within this specialty area.
Where is Amara Therapeutics Ltd. based?
Amara Therapeutics Ltd. is headquartered in Ireland, as indicated by its company registration details.
Which regulatory registries list Amara Therapeutics Ltd.’s devices?
The RiSolve device is listed in the EUDAMED database, which is the European Union’s medical device registry. This registry tracks devices that have undergone the necessary regulatory processes under EU medical device legislation.
How are Amara Therapeutics Ltd.’s devices classified under EU regulations?
The RiSolve device is classified as a Class I medical device under EU regulations. This classification is typically assigned to devices posing minimal risk to patients, often requiring less stringent regulatory oversight compared to higher-risk classes.
Information
- Country
- Ireland
- Address
- Unit 109, University of Galway Business Innovation Centre, Galway, Ireland
- Website
- www.amaratherapeutics.com/
- [email protected]
- Phone
- +353-214742968
- PRRC contact
- Emma Carr
- EUDAMED SRN
- IE-MF-000045497