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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 3 of 22

Device	Model / Reference	Registries	Class	Status
Impressions II Encore Size 11	102 11	EUDAMEDFDA UDI	Class I	Active
Partial Size 7	531 07	EUDAMEDFDA UDI	Class I	Active
Teardrop Partial Encore Size 8	356 08	EUDAMEDFDA UDI	Class I	Active
Partial Size 3	531 03	EUDAMEDFDA UDI	Class I	Active
Relax Gelcell G2 Cover Size 18x16inch	GC005-1816	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Upper Left Section / Lower Right Section	EL906	EUDAMEDFDA UDI	Class I	Active
Neoform Wrist Thumb Brace Lge/Rt	CK-NWT-04R	EUDAMED	Class I	Active
Relax Duogel With Wipeable Cover Size 20x18inch	RD006-2018	EUDAMEDFDA UDI	Class I	Active
Sublime Arís Size 14	151 14	EUDAMED	Class I	Active
Duo-Profile With Mesh/Spacer Cover Size 17x17inch	RDP009-1717	EUDAMEDFDA UDI	Class I	Active
Featherweight Size 5	615 05	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 8	616 08	EUDAMEDFDA UDI	Class I	Active
ARDS Hip Positioning Pad	ELP217	EUDAMEDFDA UDI	Class I	Active
Triangle Silk Lite Partials Dark Tone Size 8	539 08	EUDAMED	Class I	Active
Silk Triangle Size 8	471 08	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 04	624 04	EUDAMED	Class I	Active
Silk Triangle Plus Size 14	472 14	EUDAMEDFDA UDI	Class I	Active
Relax Trio Cushion Size 18x18inch	RT001-1818	EUDAMEDFDA UDI	Class I	Active
Tri Leisureform Size 3	611 03	EUDAMEDFDA UDI	Class I	Active
Relax Duogel With Wipeable Cover Size 14x14inch	RD006-1414	EUDAMEDFDA UDI	Class I	Active
Relax GelCell G2 Cushion Size 14x14inch	RG005-1414	EUDAMEDFDA UDI	Class I	Active
Assymetrical Left Size 3	498 03L	EUDAMED	Class I	Active
Breastform Cover Size 9 (102/483)	D00109	EUDAMEDFDA UDI	Class I	Active
Triangle Silk Lite Partial Beige Size 4	538 04	EUDAMEDFDA UDI	Class I	Active
Relax Trio Cushion Size 14x16inch	RT001-1416	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Open Head Ring, Adolescent	EL021	EUDAMEDFDA UDI	Class I	Active
A Supreme Right Size 8	503 8R	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 10	475R10	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 8	475R08	EUDAMEDFDA UDI	Class I	Active
Sublime Arís Size 9	151 09	EUDAMEDFDA UDI	Class I	Active
Relax Easy High Profile Cushion Size 17x17inch	REH005-1717	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 2 (102/483)	D00102	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 3	701 03	EUDAMED	Class I	Active
Luna Triangle Bronze Size 15	625 15	EUDAMED	Class I	Active
Clearview Prone Headrest	CVP01	EUDAMED	Class I	Active
E Supreme Size 16	509 16	EUDAMEDFDA UDI	Class I	Active
Tri Leisureform Size 7	611 07	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 16	495 16	EUDAMEDFDA UDI	Class I	Active
Silk Connect Size 7	476 07	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 14	624 14	EUDAMED	Class I	Active
Breastform Cover Size 01 (473/ 509)	N00501	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 8	701 08	EUDAMED	Class I	Active
Triangle Silk Lite Partials Dark Tone Size 6	539 06	EUDAMEDFDA UDI	Class I	Active
Oasis+ Short Arm Pad	OP070	EUDAMEDFDA UDI	Class I	Active
Sublime Arís Size 11	151 11	EUDAMEDFDA UDI	Class I	Active
Duogel Wipeable Cover Size 16x18inch	DWC003-1618	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 14x14inch	DC009-1414	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 06 (477)	N00606	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 24x18inch	RD003-2418	EUDAMEDFDA UDI	Class I	Active
A Supreme Right Size 12	503 12R	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