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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 11 of 22

Device	Model / Reference	Registries	Class	Status
ARDS Chest Positioning Pad	ELP215	EUDAMEDFDA UDI	Class I	Active
Partial Size 10	531 10	EUDAMED	Class I	Active
Sublime Arís Size 3	151 03	EUDAMED	Class I	Active
Cara Size 5	153 05	EUDAMEDFDA UDI	Class I	Active
Partial Size 6	531 06	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Flat Bottom Chest Roll	EL216	EUDAMEDFDA UDI	Class I	Active
Tri Leisureform Size 8	611 08	EUDAMEDFDA UDI	Class I	Active
Tri Leisureform Size 13	611 13	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 01 (478/ 482)	N007R01	EUDAMEDFDA UDI	Class I	Active
Relax Duogel With Wipeable Cover Size 18x20inch	RD006-1820	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 10	495 10	EUDAMEDFDA UDI	Class I	Active
Elite Trendelenburg Positioner	ELT900	EUDAMEDFDA UDI	Class I	Active
Oasis Extremity Belt	OA113	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 10 (475/ 503)	N008R10	EUDAMED	Class I	Active
Bella Size 4	571 04	EUDAMEDFDA UDI	Class I	Active
A Supreme Left Size 5	503 5L	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 13 (151)	N00213	EUDAMED	Class I	Active
Silk Triangle Plus Size 11	472 11	EUDAMEDFDA UDI	Class I	Active
Elite Wedge Positioner	ELP049	EUDAMEDFDA UDI	Class I	Active
Sublime Arís Size 6	151 06	EUDAMEDFDA UDI	Class I	Active
Relax Duogel With Wipeable Cover Size 17x19inch	RD006-1719	EUDAMEDFDA UDI	Class I	Active
Silk Flex Darktone Size 12	487 12	EUDAMED	Class I	Active
Oasis+ Long Arm Pad	OP101	EUDAMEDFDA UDI	Class I	Active
Bella Size 10	571 10	EUDAMEDFDA UDI	Class I	Active
Relax Gelcell Cover Size 18x16inch	GC004-1816	EUDAMEDFDA UDI	Class I	Active
Silk Connect Size 4	476 04	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 08 (151)	N00208	EUDAMED	Class I	Active
Tropez Size 5	641 05	EUDAMEDFDA UDI	Class I	Active
Trulife Clavicle Splint X-Large	CK-CLA-09	EUDAMED	Class I	Active
Breastform Cover Size 4 (102/483)	D00104	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 04 (508)	N00404	EUDAMED	Class I	Active
Oasis Universal Patient Positioners	OA050	EUDAMEDFDA UDI	Class I	Active
Silk Curve Size 12	485 12	EUDAMEDFDA UDI	Class I	Active
A Supreme Left Size 2	503 2L	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 06 (475/ 503)	N008L06	EUDAMED	Class I	Active
Silk A Supreme Left Size 4	475L04	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 05 (508)	N00405	EUDAMED	Class I	Active
A Supreme Left Size 7	503 7L	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 6	483 06	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 05 (485/ 153)	N00305	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 1	616 01	EUDAMEDFDA UDI	Class I	Active
Elite Universal Positioner	ELP011	EUDAMEDFDA UDI	Class I	Active
Relax Wipedown Easy Cushion Cover Size 14x16inch	EC004-1416	EUDAMEDFDA UDI	Class I	Active
Nelo Universal Positioner Large	NE300	EUDAMED	Class I	Active
Breastform Cover Size 11 (102/483)	D00111	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 14 (477)	N00614	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 7	475R07	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 12	483 12	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 10 (485/ 153)	N00310	EUDAMEDFDA UDI	Class I	Active
Teardrop Partial Encore Size 10	356 10	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