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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 14 of 22

Device	Model / Reference	Registries	Class	Status
Breastform Cover Right Size 06 (478/ 482)	N007R06	EUDAMEDFDA UDI	Class I	Active
Impressions II Size 9	101 09	EUDAMEDFDA UDI	Class I	Active
Luna Right Size 11	622 11R	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 07 (151)	N00207	EUDAMED	Class I	Active
Breastform Cover Left Size 10 (475/ 503)	N008L10	EUDAMED	Class I	Active
Breastform Cover Left Size 02 (497/498)	N009L02	EUDAMED	Class I	Active
Silk Xtend Left Size 12	478L12	EUDAMEDFDA UDI	Class I	Active
Assymetrical Left Size 8	498 08L	EUDAMED	Class I	Active
Duogel Standard Black Cover Size 18x18inch	DC003-1818	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Prone Positioning Base Plate	EL912	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Lateral Park Bench Positioner	EL913	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Left Size 10	478L10	EUDAMEDFDA UDI	Class I	Active
Partial Size 8	531 08	EUDAMEDFDA UDI	Class I	Active
Silk Connect Size 8	476 08	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 08 (477)	N00608	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Plus Size 6	472 06	EUDAMEDFDA UDI	Class I	Active
Triangle Silk Lite Partials Dark Tone Size 9	539 09	EUDAMED	Class I	Active
Relax Duogel With Wipeable Cover Size 22x18inch	RD006-2218	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 5	475R05	EUDAMEDFDA UDI	Class I	Active
Oasis Armboard Pads	OA070	EUDAMEDFDA UDI	Class I	Active
Silk Ultima Triangle Size 9	481 09	EUDAMEDFDA UDI	Class I	Active
Relax Trio Cushion Cover Size 16x16inch	TC001-1616	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 12	478R12	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Right Size 6	497 06R	EUDAMED	Class I	Active
Relax Duogel Mesh Cover Size 19x18inch	DC009-1918	EUDAMEDFDA UDI	Class I	Active
Tropez Size 10	641 10	EUDAMEDFDA UDI	Class I	Active
Cara Size 11	153 11	EUDAMEDFDA UDI	Class I	Active
Partial Size 5	531 05	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 17 (101/471/472/476/481/490/495/571/701)	N00117	EUDAMED	Class I	Active
Silk Flex Size 12	477 12	EUDAMEDFDA UDI	Class I	Active
Impressions II Size 6	101 06	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 03 (475/ 503)	N008L03	EUDAMED	Class I	Active
Duogel Wipeable Cover Size 15x17inch	DWC003-1517	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 12 (477)	N00612	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 15x17inch	RD003-1517	EUDAMEDFDA UDI	Class I	Active
Tri Leisureform Size 11	611 11	EUDAMEDFDA UDI	Class I	Active
Tropez Size 6	641 06	EUDAMEDFDA UDI	Class I	Active
Duogel Wipeable Cover Size 24x18inch	DWC003-2418	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 05 (478/ 482)	N007R05	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Right Size 8	497 08R	EUDAMED	Class I	Active
E Supreme Size 7	509 07	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 11 (473/ 509)	N00511	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 6	701 06	EUDAMED	Class I	Active
Breastform Cover Size 11 (101/471/472/476/481/490/495/571/701)	N00111	EUDAMED	Class I	Active
Breastform Cover Left Size 12 (475/ 503)	N008L12	EUDAMED	Class I	Active
Duo-Profile With Standard Black Cover Size 17x17inch	RDP003-1717	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 10 (508)	N00410	EUDAMED	Class I	Active
Tri Leisureform Size 14	611 14	EUDAMEDFDA UDI	Class I	Active
Impressions II Encore Size 5	102 05	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 05 (497/498)	N009R05	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