Trulife
Active in EUDAMEDIrelandfrom SRN EUDAMED FDA SRN IE-MF-000003108
- Devices
- 1,061
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Trulife makes
Trulife manufactures a range of breast prostheses, including custom-fitted covers like the Breastform Cover Right Size 07 and Left Size 03, as well as silicone-based forms such as the Luna Right Size 5 and Silk Flex Darktone Size 06. Their portfolio also includes positioning aids like the Oasis Universal Patient Positioners and wrist braces, including the TRULIFE PK 6 SML/LT Classic Wrist BR. Additional products include table pads like the Oasis Elite ¾ Table Pad and various silicone pads and triangles, such as the Featherweight Size 17 and Silk Encore Triangle Size 8.
All listed devices fall under Class I of the EU Medical Device Regulation, ensuring compliance with basic safety and performance requirements. These products are registered in the EU’s eudamed database, reflecting their authorised status for distribution within the European market. The company is based in Ireland.
Catalogue
Search and filter all 1,061 devicesShowing 1-50 of 1,061
Company details
- EUDAMED SRN
- IE-MF-000003108
- EUDAMED status
- Active
- EUDAMED registered name
- Trulife
- Registered address
- Airton Road, D24 R859, Dublin 24, Ireland
- Website
- www.trulife.com
- [email protected]
- Phone
- +35314511755
- PRRC contact
- Rebecca Holmes
FDA establishments
- Trulife Limited TRENTON Ontario · CA FEI 3001267839
- Trulife Ltd GB
From the company website
Trulife is internationally based with over 60 years’ experience in the creation, development, manufacture of niche healthcare and consumer products.
Frequently asked questions
How many devices does Trulife have in the registry?
The registry currently lists 1061 devices for Trulife. Devices recorded under merged duplicate company entries are counted once.
Which registries list Trulife's devices?
Among its 50 most recently registered devices, Trulife has devices listed in EUDAMED (50 devices) and FDA GUDID (36 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Trulife's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Trulife's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Trulife in the registry?
The most recently registered devices listed for Trulife include Luna Right Size 5, Featherweight Size 17, TRULIFE PK 6 SML/LT CLASSIC WRIST BR and Oasis Elite ¾ Table Pad.
Which FDA establishments are linked to Trulife?
2 FDA establishments are linked to Trulife in the registry; they are listed on the company page.