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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 13 of 22

Device	Model / Reference	Registries	Class	Status
Bella Size 11	571 11	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 14	483 14	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 6	475R06	EUDAMEDFDA UDI	Class I	Active
Silk Teardrop Size 4	473 04	EUDAMEDFDA UDI	Class I	Active
Relax Duogel With Wipeable Cover Size 16x16inch	RD006-1616	EUDAMEDFDA UDI	Class I	Active
Oasis Paediatric Full Length Pad	OA033	EUDAMEDFDA UDI	Class I	Active
Silk Flex Darktone Size 10	487 10	EUDAMED	Class I	Active
Tri Featherwieight Size 6	616 06	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Right Size 2	497 02R	EUDAMED	Class I	Active
Oasis Open Head Ring Adult	OA022	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 07 (473/ 509)	N00507	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Left Size 6	478L06	EUDAMEDFDA UDI	Class I	Active
Partial Size 2	531 02	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 16 (102/483)	D00116	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 17x17inch	RD003-1717	EUDAMEDFDA UDI	Class I	Active
A Supreme Right Size 9	503 9R	EUDAMEDFDA UDI	Class I	Active
Oasis Face Pad	OA140	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 19x16inch	RD003-1916	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 9	701 09	EUDAMED	Class I	Active
ARDS Prone Pad System	ELP200	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 14	478R14	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 04 (473/ 509)	N00504	EUDAMEDFDA UDI	Class I	Active
Partial Size 9	531 09	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 09 (508)	N00409	EUDAMED	Class I	Active
Silk Ultima Triangle Size 13	481 13	EUDAMEDFDA UDI	Class I	Active
Tri Leisureform Size 5	611 05	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 8 (101/471/472/476/481/490/495/571/701)	N00108	EUDAMED	Class I	Active
Luna Triangle Bronze Size 10	625 10	EUDAMED	Class I	Active
Azure Sacral Protector (Small)	AZ300	EUDAMEDFDA UDI	Class I	Active
Silk Flex Darktone Size 07	487 07	EUDAMED	Class I	Active
Silk Curve Size 2	485 02	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 17	483 17	EUDAMEDFDA UDI	Class I	Active
Triangular Partial Size 5	533 05	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 05 (151)	N00205	EUDAMED	Class I	Active
ARDS Stomach Positioning Pad	ELP216	EUDAMEDFDA UDI	Class I	Active
Assymetrical Right Size 10	498 10R	EUDAMED	Class I	Active
Tropez Size 9	641 09	EUDAMEDFDA UDI	Class I	Active
Duogel Wipeable Cover Size 18x18inch	DWC003-1818	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Left Size 9	62309L	EUDAMED	Class I	Active
Breastform Cover Size 11 (485/ 153)	N00311	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 06	624 06	EUDAMED	Class I	Active
Relax GelCell G2 Cushion Size 15x15inch	RG005-1515	EUDAMEDFDA UDI	Class I	Active
Relax Duogel With Wipeable Cover Size 16x18inch	RD006-1618	EUDAMEDFDA UDI	Class I	Active
Silk Ultima Triangle Size 6	481 06	EUDAMEDFDA UDI	Class I	Active
Relax GelCell Cushion Size 18x16inch	RG004-1816	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Arm/Knee Pad Large	EL401	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Right Size 4	497 04R	EUDAMED	Class I	Active
Triangle Silk Lite Partial Beige Size 9	538 09	EUDAMEDFDA UDI	Class I	Active
Oasis Foot Section	OA038	EUDAMED	Class I	Active
Silk Curve Size 8	485 08	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