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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 9 of 22

Device	Model / Reference	Registries	Class	Status
Elite Trendelenburg System 20°	ELTS20	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 02 (475/ 503)	N008R02	EUDAMED	Class I	Active
E Supreme Size 10	509 10	EUDAMEDFDA UDI	Class I	Active
Oasis Perineal Table Pads	OA040	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 05 (477)	N00605	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 08 (508)	N00408	EUDAMED	Class I	Active
Breastform Cover Left Size 12 (478/ 482)	N007L12	EUDAMEDFDA UDI	Class I	Active
Tropez Size 7	641 07	EUDAMEDFDA UDI	Class I	Active
Neoform Wrist Thumb Brace Sml/Lt	CK-NWT-02L	EUDAMED	Class I	Active
Silk Triangle Plus Size 3	472 03	EUDAMEDFDA UDI	Class I	Active
Symphony Size 1	508 01	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Left Size 3	478L03	EUDAMEDFDA UDI	Class I	Active
Triangular Partial Size 4	533 04	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Size 1	471 01	EUDAMEDFDA UDI	Class I	Active
Duogel Wipeable Cover Size 20x18inch	DWC003-2018	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 5 (102/483)	D00105	EUDAMEDFDA UDI	Class I	Active
Tropez Size 4	641 04	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 12	616 12	EUDAMEDFDA UDI	Class I	Active
Oasis Flat Bottom Chest Roll	OA212	EUDAMEDFDA UDI	Class I	Active
Duogel Wipeable Cover Size 22x18inch	DWC003-2218	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 5	478R05	EUDAMEDFDA UDI	Class I	Active
Symphony Size 8	508 08	EUDAMEDFDA UDI	Class I	Active
Duogel Standard Black Cover Size 19x16inch	DC003-1916	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Large Prone Positioner	EL904	EUDAMEDFDA UDI	Class I	Active
Tropez Size 11	641 11	EUDAMEDFDA UDI	Class I	Active
Teardrop Partial Encore Size 6	356 06	EUDAMEDFDA UDI	Class I	Active
Teardrop Silk Lite Partial Beige Size 7	536 07	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 02 (478/ 482)	N007L02	EUDAMEDFDA UDI	Class I	Active
Luna Left Size 6	622 06L	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Left Size 10	497 10L	EUDAMED	Class I	Active
Oasis Elite Dome Positioner	EL210	EUDAMEDFDA UDI	Class I	Active
A Supreme Left Size 10	503 10L	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 06 (473/ 509)	N00506	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 1	483 01	EUDAMEDFDA UDI	Class I	Active
Relax GelCell Cushion Size 15x14inch	RG004-1514	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 13	495 13	EUDAMEDFDA UDI	Class I	Active
Silk Connect Size 2	476 02	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 2	483 02	EUDAMEDFDA UDI	Class I	Active
Symphony Size 11	508 11	EUDAMEDFDA UDI	Class I	Active
Relax Easy High Profile Wipedown Black Outer Cover Size 18x18inch	ECH005-1818	EUDAMEDFDA UDI	Class I	Active
Neoform Wrist Thumb Brace Xs/Rt	CK-NWT-01R	EUDAMED	Class I	Active
BodiCool Assymetrical Right Size 10	497 10R	EUDAMED	Class I	Active
Assymetrical Right Size 6	498 06R	EUDAMED	Class I	Active
Breastform Cover Left Size 11 (478/ 482)	N007L11	EUDAMEDFDA UDI	Class I	Active
Bella Size 12	571 12	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 08	624 08	EUDAMED	Class I	Active
Breastform Cover Right Size 05 (475/ 503)	N008R05	EUDAMED	Class I	Active
Silk A Supreme Left Size 7	475L07	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Plus Size 4	472 04	EUDAMEDFDA UDI	Class I	Active
Teardrop Silk Lite Partial Beige Size 5	536 05	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