Trulife
IE-MF-000003108 · Ireland · Dublin 24
Trulife is registered in the European database on medical devices as a manufacturer, with 1 061 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 061 |
|---|
Most frequent device types declared: Breastcare, Orthopaedic Support Braces, Pre-Op Gloves, PressureCare, Relax.
Devices declared under this manufacturer
- A Supreme Left Size 14
- ARDS Prone Headrest Pad (x3)
- Breastform Cover Left Size 09 (497/498)
- Breastform Cover Size 03 (477)
- Luna Triangle Beige Size 17
- Oasis Head Section
- Oasis Universal Profile Pad
- Relax Duogel Mesh Cover Size 17x20inch
- Relax Duogel With Wipeable Cover Size 17x17inch
- Silk A Supreme Left Size 13
- Silk A Supreme Right Size 1
- Silk Teardrop Size 6
Showing 12 of 1 061 declared devices.
Catalogue references include 473 09, 475L13, 478L08, 624 17, DC009-1720, ELP141.
European nomenclature codes declared: V9099, V080399, V0899, Y060612, Y061215, Y060613.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TRULIFE LIMITED (CA) · FDA 9615374 |
| Devices in EUDAMED | 1 061 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 1 061 |
|---|---|
| Found in the U.S. device database | 782 |
| Share | 73.7 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Trulife is registered in the United States but was not found in the Canadian register.