Is this your brand? Sign in to claim ownership.

Trulife

Ireland·IE-MF-000003108

Last updated September 18, 2026

About

Trulife is internationally based with over 60 years’ experience in the creation, development, manufacture of niche healthcare and consumer products.

From the manufacturer's own website. Source

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Ireland
Address: Airton Road, Dublin 24, Ireland
Website: www.trulife.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +35314511755
PRRC Contact: Rebecca Holmes
EUDAMED SRN: IE-MF-000003108
FDA FEI Number: —
DUNS Number: —

Catalogue (1061)

Page 12 of 22

Device	Model / Reference	Registries	Class	Status
Oasis Elite Flat Bottom Chest Roll	EL215	EUDAMEDFDA UDI	Class I	Active
Relax Trio Cushion Cover Size 14x16inch	TC001-1416	EUDAMEDFDA UDI	Class I	Active
Partial Size 4	531 04	EUDAMEDFDA UDI	Class I	Active
Duo-Profile With Mesh/Spacer Cover Size 16x16inch	RDP009-1616	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 1	478R01	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 08 (475/ 503)	N008R08	EUDAMED	Class I	Active
Relax Easy High Profile Cushion Size 20x20inch	REH005-2020	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 6	478R06	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 02 (473/ 509)	N00502	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 08 (485/ 153)	N00308	EUDAMEDFDA UDI	Class I	Active
Silk Flex Size 9	477 09	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Right Size 9	497 09R	EUDAMED	Class I	Active
Neoform Wrist Thumb Brace Med/Lt	CK-NWT-03L	EUDAMED	Class I	Active
Relax Gelcell G2 Cover Size 16x18inch	GC005-1618	EUDAMEDFDA UDI	Class I	Active
Teardrop Silk Lite Partial Beige Size 3	536 03	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Plus Size 16	472 16	EUDAMED	Class I	Active
Silk Flex Size 5	477 05	EUDAMEDFDA UDI	Class I	Active
Teardrop Partial Encore Size 7	356 07	EUDAMEDFDA UDI	Class I	Active
Duo=Profile With Wipeable Cover Size 18x18inch	RDP006-1818	EUDAMEDFDA UDI	Class I	Active
Assymetrical Right Size 5	498 05R	EUDAMED	Class I	Active
Assymetrical Right Size 7	498 07R	EUDAMED	Class I	Active
Breastform Cover Right Size 09 (478/ 482)	N007R09	EUDAMEDFDA UDI	Class I	Active
Silk Flex Size 13	477 13	EUDAMED	Class I	Active
Duogel Wipeable Cover Size 15x14inch	DWC003-1514	EUDAMEDFDA UDI	Class I	Active
Relax Gelcell G2 Cover Size 17x17inch	GC005-1717	EUDAMEDFDA UDI	Class I	Active
Relax Duogel With Wipeable Cover Size 18x16inch	RD006-1816	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Left Size 13	475L13	EUDAMEDFDA UDI	Class I	Active
A Supreme Right Size 6	503 6R	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Left Size 10	62310L	EUDAMED	Class I	Active
Silk Teardrop Size 8	473 08	EUDAMEDFDA UDI	Class I	Active
Sublime Arís Size 8	151 08	EUDAMEDFDA UDI	Class I	Active
A Supreme Right Size 10	503 10R	EUDAMEDFDA UDI	Class I	Active
Triangle Silk Lite Partial Beige Size 5	538 05	EUDAMEDFDA UDI	Class I	Active
Featherweight Size 11	615 11	EUDAMEDFDA UDI	Class I	Active
Impressions II Size 7	101 07	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 10	478R10	EUDAMEDFDA UDI	Class I	Active
Relax Wipedown Easy Cushion Cover Size 18x16inch	EC004-1816	EUDAMEDFDA UDI	Class I	Active
Silk Flex Darktone Size 05	487 05	EUDAMED	Class I	Active
Lennox Hill 3 Panel Immob Ex Large	CK-BTP04	EUDAMED	Class I	Active
Triangular Partial Size 8	533 08	EUDAMEDFDA UDI	Class I	Active
Relax Gelcell Cover Size 17x17inch	GC004-1717	EUDAMEDFDA UDI	Class I	Active
Silk Ultima Triangle Size 2	481 02	EUDAMEDFDA UDI	Class I	Active
Impressions II Size 11	101 11	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Left Size 8	478L08	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 09	624 09	EUDAMED	Class I	Active
Relax Duogel With Wipeable Cover Size 18x18inch	RD006-1818	EUDAMEDFDA UDI	Class I	Active
Luna Left Size 5	622 05L	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 04 (497/498)	N009L04	EUDAMED	Class I	Active
A Supreme Left Size 14	503 14L	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 11 (475/ 503)	N008R11	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Trulife Limited TRENTON Ontario · CA FEI 3001267839
Trulife Ltd GB