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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 8 of 22

Device	Model / Reference	Registries	Class	Status
Triangle Silk Lite Partial Beige Size 6	538 06	EUDAMEDFDA UDI	Class I	Active
Relax Easy Cushion Size 22x18inch	RE005-2218	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 7 (101/471/472/476/481/490/495/571/701)	N00107	EUDAMED	Class I	Active
Prone Positioning Pad	ELP914	EUDAMED	Class I	Active
Silk Flex Darktone Size 01	487 01	EUDAMED	Class I	Active
Silk Xtend Left Size 13	478L13	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 14 (478/ 482)	N007R14	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 10 (478/ 482)	N007L10	EUDAMEDFDA UDI	Class I	Active
Duo-Profile With Standard Black Cover Size 16x16inch	RDP003-1616	EUDAMEDFDA UDI	Class I	Active
A Supreme Left Size 6	503 6L	EUDAMEDFDA UDI	Class I	Active
Assymetrical Right Size 9	498 09R	EUDAMED	Class I	Active
BodiCool Assymetrical Left Size 2	497 02L	EUDAMED	Class I	Active
Relax Trio Cushion Size 16x16inch	RT001-1616	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Left Size 1	478L01	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Right Size 8	62308R	EUDAMED	Class I	Active
Silk A Supreme Left Size 2	475L02	EUDAMEDFDA UDI	Class I	Active
Pavlik Harness White No Bootees Xs	CK-T871201	EUDAMED	Class I	Active
Teardrop Silk Lite Partials Dark Tone Size 6	537 06	EUDAMEDFDA UDI	Class I	Active
Triangle Silk Lite Partial Beige Size 3	538 03	EUDAMEDFDA UDI	Class I	Active
Relax Gelcell G2 Cover Size 15x15inch	GC005-1515	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Bronze Size 13	625 13	EUDAMED	Class I	Active
Teardrop Silk Lite Partials Dark Tone Size 8	537 08	EUDAMEDFDA UDI	Class I	Active
Trulife Pk 6 Xl/Rt Classic Wrist Br	CK-FTC-05R	EUDAMED	Class I	Active
Duogel Standard Black Cover Size 16x18inch	DC003-1618	EUDAMEDFDA UDI	Class I	Active
Silk Ultima Triangle Size 12	481 12	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 3	475R03	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 13 (475/ 503)	N008L13	EUDAMED	Class I	Active
BodiCool Wave Triangle Size 14	495 14	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 11	701 11	EUDAMED	Class I	Active
Relax Trio Cushion Size 18x16inch	RT001-1816	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 11 (475/ 503)	N008L11	EUDAMED	Class I	Active
Relax Easy High Profile Cushion Size 18x18inch	REH005-1818	EUDAMEDFDA UDI	Class I	Active
ARDS Prone Headrest Pad (x3)	ELP141	EUDAMEDFDA UDI	Class I	Active
Pavlik Harness White No Bootees M	CK-T871203	EUDAMED	Class I	Active
Tri Leisureform Size 12	611 12	EUDAMEDFDA UDI	Class I	Active
Triangle Silk Lite Partials Dark Tone Size 7	539 07	EUDAMEDFDA UDI	Class I	Active
A Supreme Left Size 1	503 1L	EUDAMEDFDA UDI	Class I	Active
Featherweight Size 13	615 13	EUDAMEDFDA UDI	Class I	Active
Lennox Hill 3 Panel Immob Medium	CK-BTP-00	EUDAMED	Class I	Active
Silk Triangle Plus Size 17	472 17	EUDAMED	Class I	Active
Oasis Closed Head Ring Paediatric	OA010	EUDAMEDFDA UDI	Class I	Active
Triangular Partial Size 6	533 06	EUDAMEDFDA UDI	Class I	Active
Oasis + Universal Profile Pad	OP041	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Plus Size 1	472 01	EUDAMEDFDA UDI	Class I	Active
Oasis Thigh Pad	OA094	EUDAMED	Class I	Active
Silk Flex Darktone Size 13	487 13	EUDAMED	Class I	Active
Oasis + Heel Pads	OP130	EUDAMED	Class I	Active
Featherweight Size 16	615 16	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 17x19inch	DC009-1719	EUDAMEDFDA UDI	Class I	Active
Pavlik Harness White With Bootees Xs	CK-T871601	EUDAMED	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