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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 21 of 22

Device	Model / Reference	Registries	Class	Status
Luna Bronze Left Size 12	62312L	EUDAMED	Class I	Active
Silk Flex Size 14	477 14	EUDAMED	Class I	Active
Impressions II Size 3	101 03	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Prone Chest Positioner	EL903	EUDAMEDFDA UDI	Class I	Active
Featherweight Size 10	615 10	EUDAMEDFDA UDI	Class I	Active
Luna Right Size 8	622 08R	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Plus Size 10	472 10	EUDAMEDFDA UDI	Class I	Active
Relax Wipedown Easy Cushion Cover Size 17x17inch	EC004-1717	EUDAMEDFDA UDI	Class I	Active
Azure Arm Protector (Short)	AZ200	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 13 (473/ 509)	N00513	EUDAMEDFDA UDI	Class I	Active
Oasis Universal Patient Positioners	OA051	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 1 (101/471/472/476/481/490/495/571/701)	N00101	EUDAMED	Class I	Active
Breastform Cover Size 08 (473/ 509)	N00508	EUDAMEDFDA UDI	Class I	Active
Silk Teardrop Size 12	473 12	EUDAMEDFDA UDI	Class I	Active
Relax Duogel With Wipeable Cover Size 20x20inch	RD006-2020	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 17x16inch	DC009-1716	EUDAMEDFDA UDI	Class I	Active
Relax Easy High Profile Wipedown Black Outer Cover Size 18x16inch	ECH005-1816	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 07 (485/ 153)	N00307	EUDAMEDFDA UDI	Class I	Active
Silk Ultima Triangle Size 11	481 11	EUDAMEDFDA UDI	Class I	Active
Pavlik Harness White With Bootees Large	CK-T871604	EUDAMED	Class I	Active
Tri Partial Encore Size 4	535 04	EUDAMEDFDA UDI	Class I	Active
Cara Size 7	153 07	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 16	624 16	EUDAMED	Class I	Active
Breastform Cover Size 09 (473/ 509)	N00509	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Size 12	471 12	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 17	495 17	EUDAMEDFDA UDI	Class I	Active
Relax Easy Cushion Size 14x18inch	RE005-1418	EUDAMEDFDA UDI	Class I	Active
Pavlik Harness White No Bootees S	CK-T871202	EUDAMED	Class I	Active
Tri Leisureform Size 10	611 10	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 3	478R03	EUDAMEDFDA UDI	Class I	Active
Silk Connect Size 5	476 05	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 16x18inch	RD003-1618	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Plus Size 7	472 07	EUDAMEDFDA UDI	Class I	Active
Elite Roll Positioner	ELP214	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 04 (475/ 503)	N008L04	EUDAMED	Class I	Active
Breastform Cover Left Size 07 (478/ 482)	N007L07	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 01 (477)	N00601	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 10 (497/498)	N009R10	EUDAMED	Class I	Active
Silk A Supreme Right Size 13	475R13	EUDAMEDFDA UDI	Class I	Active
Silk Teardrop Size 10	473 10	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 6 (101/471/472/476/481/490/495/571/701)	N00106	EUDAMED	Class I	Active
Silk Flex Size 1	477 01	EUDAMEDFDA UDI	Class I	Active
Duogel Wipeable Cover Size 16x16inch	DWC003-1616	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Size 9	471 09	EUDAMEDFDA UDI	Class I	Active
Silk Flex Size 8	477 08	EUDAMEDFDA UDI	Class I	Active
Tri Leisureform Size 4	611 04	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 05	624 05	EUDAMED	Class I	Active
Silk Triangle Size 13	471 13	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 17x17inch	DC009-1717	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 03 (477)	N00603	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