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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 16 of 22

Device	Model / Reference	Registries	Class	Status
Featherweight Size 6	615 06	EUDAMEDFDA UDI	Class I	Active
E Supreme Size 4	509 04	EUDAMEDFDA UDI	Class I	Active
Teardrop Partial Encore Size 9	356 09	EUDAMEDFDA UDI	Class I	Active
Silk Curve Size 14	485 14	EUDAMEDFDA UDI	Class I	Active
Symphony Size 13	508 13	EUDAMEDFDA UDI	Class I	Active
Tropez Size 8	641 08	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 17 (102/483)	D00117	EUDAMEDFDA UDI	Class I	Active
Assymetrical Right Size 3	498 03R	EUDAMED	Class I	Active
Breastform Cover Right Size 11 (478/ 482)	N007R11	EUDAMEDFDA UDI	Class I	Active
Bella Size 8	571 08	EUDAMEDFDA UDI	Class I	Active
E Supreme Size 2	509 02	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Left Size 14	475L14	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 12 (508)	N00412	EUDAMED	Class I	Active
BodiCool Wave Triangle Size 11	495 11	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 13 (478/ 482)	N007L13	EUDAMEDFDA UDI	Class I	Active
Relax Easy High Profile Wipedown Black Outer Cover Size 16x16inch	ECH005-1616	EUDAMEDFDA UDI	Class I	Active
Teardrop Partial Encore Size 4	356 04	EUDAMEDFDA UDI	Class I	Active
Featherweight Size 4	615 04	EUDAMEDFDA UDI	Class I	Active
Silk Teardrop Size 13	473 13	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Left Size 3	497 03L	EUDAMED	Class I	Active
Luna Left Size 7	622 07L	EUDAMEDFDA UDI	Class I	Active
Luna Left Size 12	622 12L	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Left Size 8	475L08	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 10	701 10	EUDAMED	Class I	Active
BodiCool Assymetrical Left Size 6	497 06L	EUDAMED	Class I	Active
Silk Curve Size 11	485 11	EUDAMEDFDA UDI	Class I	Active
Wrap Around Hinged Knee Supp Ex Large	CK-PT12405	EUDAMED	Class I	Active
BodiCool Assymetrical Left Size 5	497 05L	EUDAMED	Class I	Active
ET Shoulder Support (Pair)	ELT21	EUDAMEDFDA UDI	Class I	Active
Teardrop Silk Lite Partials Dark Tone Size 7	537 07	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 9 (101/471/472/476/481/490/495/571/701)	N00109	EUDAMED	Class I	Active
Azure Universal Patient Positioner	AZ500	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 04 (497/498)	N009R04	EUDAMED	Class I	Active
Breastform Cover Right Size 12 (475/ 503)	N008R12	EUDAMED	Class I	Active
Operating Universal Table Pad	OA030	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Right Size 7	497 07R	EUDAMED	Class I	Active
Luna Bronze Left Size 5	62305L	EUDAMED	Class I	Active
Breastform Cover Size 5 (101/471/472/476/481/490/495/571/701)	N00105	EUDAMED	Class I	Active
Duo=Profile With Wipeable Cover Size 18x16inch	RDP006-1816	EUDAMEDFDA UDI	Class I	Active
Cara Size 4	153 04	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 18x20inch	RD003-1820	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Right Size 5	497 05R	EUDAMED	Class I	Active
Duo-Profile With Mesh/Spacer Cover Size 18x18inch	RDP009-1818	EUDAMEDFDA UDI	Class I	Active
Tropez Size 1	641 01	EUDAMEDFDA UDI	Class I	Active
Relax Wipedown Easy Cushion Cover Size 18x20inch	EC004-1820	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 2	495 02	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 02 (477)	N00602	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 1	701 01	EUDAMED	Class I	Active
Breastform Cover Size 16 (473/ 509)	N00516	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 3 (102/483)	D00103	EUDAMEDFDA UDI	Class I	Active

Related Companies

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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