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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 18 of 22

Device	Model / Reference	Registries	Class	Status
Relax Easy High Profile Cushion Size 18x16inch	REH005-1816	EUDAMEDFDA UDI	Class I	Active
Bella Size 6	571 06	EUDAMEDFDA UDI	Class I	Active
Wrap Around Hinged Knee Supp Medium	CK-PT12403	EUDAMED	Class I	Active
Breastform Cover Right Size 13 (478/ 482)	N007R13	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 24x18inch	DC009-2418	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Bronze Size 09	625 09	EUDAMED	Class I	Active
Pavlik Harness White No Bootees Xxs	CK-T871200	EUDAMED	Class I	Active
Oasis 3/4 Length Table Pad	OA031	EUDAMEDFDA UDI	Class I	Active
Sublime Arís Size 12	151 12	EUDAMEDFDA UDI	Class I	Active
Assymetrical Left Size 9	498 09L	EUDAMED	Class I	Active
Trulife Clavicle Splint Small	CK-CLA-03	EUDAMED	Class I	Active
Breastform Cover Size 8 (102/483)	D00108	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Left Size 7	478L07	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 6 (102/483)	D00106	EUDAMEDFDA UDI	Class I	Active
Featherweight Size 3	615 03	EUDAMEDFDA UDI	Class I	Active
Relax Easy Cushion Size 18x20inch	RE005-1820	EUDAMEDFDA UDI	Class I	Active
Silk Connect Size 1	476 01	EUDAMEDFDA UDI	Class I	Active
Teardrop Silk Lite Partial Beige Size 4	536 04	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 14 (485/ 153)	N00314	EUDAMEDFDA UDI	Class I	Active
Featherweight Size 9	615 09	EUDAMEDFDA UDI	Class I	Active
Silk Flex Darktone Size 09	487 09	EUDAMED	Class I	Active
A Supreme Left Size 11	503 11L	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Flat Bottom Chest Roll	EL214	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 11 (508)	N00411	EUDAMED	Class I	Active
Luna Bronze Right Size 5	62305R	EUDAMED	Class I	Active
Oasis Elite Flat Bottom Chest Roll	EL217	EUDAMEDFDA UDI	Class I	Active
Incline Boost	ELP802	EUDAMED	Class I	Active
Tropez Size 13	641 13	EUDAMEDFDA UDI	Class I	Active
Relax Wipedown Easy Cushion Cover Size 16x16inch	EC004-1616	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 03 (508)	N00403	EUDAMED	Class I	Active
Relax Duogel Mesh Cover Size 20x20inch	DC009-2020	EUDAMEDFDA UDI	Class I	Active
Duogel Standard Black Cover Size 17x18inch	DC003-1718	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 12	701 12	EUDAMED	Class I	Active
Breastform Cover Right Size 03 (497/498)	N009R03	EUDAMED	Class I	Active
Relax Gelcell Cover Size 20x18inch	GC004-2018	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 11	624 11	EUDAMED	Class I	Active
Oasis Full Length Table Pad	OA032	EUDAMEDFDA UDI	Class I	Active
Teardrop Silk Lite Partials Dark Tone Size 4	537 04	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Size 10	471 10	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 09 (151)	N00209	EUDAMED	Class I	Active
Re-Cover Shell Size Small	822S	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 13 (102/483)	D00113	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 12	495 12	EUDAMEDFDA UDI	Class I	Active
Symphony Size 4	508 04	EUDAMEDFDA UDI	Class I	Active
Relax Gelcell G2 Cover Size 16x16inch	GC005-1616	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 16x18inch	DC009-1618	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Left Size 8	62308L	EUDAMED	Class I	Active
Silk Ultima Triangle Size 4	481 04	EUDAMEDFDA UDI	Class I	Active
E Supreme Size 1	509 01	EUDAMEDFDA UDI	Class I	Active
A Supreme Right Size 4	503 4R	EUDAMEDFDA UDI	Class I	Active

Related Companies

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Authorities

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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