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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 2 of 22

Device	Model / Reference	Registries	Class	Status
Breastform Cover Size 06 (151)	N00206	EUDAMED	Class I	Active
Silk A Supreme Left Size 10	475L10	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 14 (101/471/472/476/481/490/495/571/701)	N00114	EUDAMED	Class I	Active
Silk Teardrop Size 7	473 07	EUDAMEDFDA UDI	Class I	Active
Relax Easy High Profile Cushion Size 16x16inch	REH005-1616	EUDAMEDFDA UDI	Class I	Active
Relax Gelcell G2 Cover Size 14x14inch	GC005-1414	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 2	616 02	EUDAMEDFDA UDI	Class I	Active
E Supreme Size 11	509 11	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Plus Size 15	472 15	EUDAMED	Class I	Active
Breastform Cover Size 04 (485/ 153)	N00304	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 01 (475/ 503)	N008R01	EUDAMED	Class I	Active
Impressions II Encore Size 6	102 06	EUDAMEDFDA UDI	Class I	Active
Oasis+ Heel Protectors	OP132	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 20x18inch	DC009-2018	EUDAMEDFDA UDI	Class I	Active
E Supreme Size 6	509 06	EUDAMEDFDA UDI	Class I	Active
A Supreme Right Size 14	503 14R	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 15 (101/471/472/476/481/490/495/571/701)	N00115	EUDAMED	Class I	Active
Relax GelCell Cushion Size 20x18inch	RG004-2018	EUDAMEDFDA UDI	Class I	Active
E Supreme Size 13	509 13	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 11	475R11	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 20x18inch	RD003-2018	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Left Size 6	62306L	EUDAMED	Class I	Active
Relax Easy High Profile Wipedown Black Outer Cover Size 18x20inch	ECH005-1820	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 8	478R08	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 08 (497/498)	N009L08	EUDAMED	Class I	Active
Silk Connect Size 6	476 06	EUDAMEDFDA UDI	Class I	Active
Assymetrical Left Size 5	498 05L	EUDAMED	Class I	Active
Tri Leisureform Size 9	611 09	EUDAMEDFDA UDI	Class I	Active
Bella Size 5	571 05	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 4	478R04	EUDAMEDFDA UDI	Class I	Active
Silk Flex Size 10	477 10	EUDAMEDFDA UDI	Class I	Active
Luna Left Size 9	622 09L	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 17x18inch	RD003-1718	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 17x16inch	RD003-1716	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 15	624 15	EUDAMED	Class I	Active
Trulife Pk 6 Xl/Lt Classic Wrist Br	CK-FTC-05L	EUDAMED	Class I	Active
Breastform Cover Size 14 (473/ 509)	N00514	EUDAMEDFDA UDI	Class I	Active
ARDS Shin Positioning Pad	ELP218	EUDAMEDFDA UDI	Class I	Active
Silk Curve Size 3	485 03	EUDAMEDFDA UDI	Class I	Active
Teardrop Partial Encore Size 2	356 02	EUDAMEDFDA UDI	Class I	Active
Trulife Pk 6 Xs/Rt Classic Wrist Br	CK-FTC-01R	EUDAMED	Class I	Active
Duo-Profile With Standard Black Cover Size 18x16inch	RDP003-1816	EUDAMEDFDA UDI	Class I	Active
Featherweight Size 2	615 02	EUDAMEDFDA UDI	Class I	Active
Luna Right Size 4	622 04R	EUDAMEDFDA UDI	Class I	Active
Silk Curve Size 7	485 07	EUDAMEDFDA UDI	Class I	Active
A Supreme Left Size 9	503 9L	EUDAMEDFDA UDI	Class I	Active
Teardrop Silk Lite Partial Beige Size 8	536 08	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 11 (151)	N00211	EUDAMED	Class I	Active
BodiCool Assymetrical Left Size 4	497 04L	EUDAMED	Class I	Active
Silk Flex Darktone Size 04	487 04	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