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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 15 of 22

Device	Model / Reference	Registries	Class	Status
Tri Partial Encore Size 6	535 06	EUDAMEDFDA UDI	Class I	Active
Relax Duogel With Wipeable Cover Size 15x17inch	RD006-1517	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 20x16inch	RD003-2016	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 14 (478/ 482)	N007L14	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 13	483 13	EUDAMEDFDA UDI	Class I	Active
Oasis Arm Retainer Pad	OA100	EUDAMEDFDA UDI	Class I	Active
Relax Easy Cushion Size 14x16inch	RE005-1416	EUDAMEDFDA UDI	Class I	Active
Cara Size 6	153 06	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 12 (485/ 153)	N00312	EUDAMEDFDA UDI	Class I	Active
Sublime Arís Size 13	151 13	EUDAMED	Class I	Active
Silk Teardrop Size 9	473 09	EUDAMEDFDA UDI	Class I	Active
Silk Flex Darktone Size 11	487 11	EUDAMED	Class I	Active
Incline Positioning System	ELP800	EUDAMED	Class I	Active
Cara Size 3	153 03	EUDAMEDFDA UDI	Class I	Active
Triangle Silk Lite Partials Dark Tone Size 3	539 03	EUDAMEDFDA UDI	Class I	Active
Oasis Contoured Armboard Pad	OA101	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 05 (497/498)	N009L05	EUDAMED	Class I	Active
Tri Featherwieight Size 5	616 05	EUDAMEDFDA UDI	Class I	Active
Bella Size 3	571 03	EUDAMEDFDA UDI	Class I	Active
E Supreme Size 3	509 03	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Left Size 11	62311L	EUDAMED	Class I	Active
A Supreme Left Size 13	503 13L	EUDAMEDFDA UDI	Class I	Active
Sublime Arís Size 10	151 10	EUDAMEDFDA UDI	Class I	Active
E Supreme Size 15	509 15	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 06 (508)	N00406	EUDAMED	Class I	Active
Luna Triangle Bronze Size 12	625 12	EUDAMED	Class I	Active
Breastform Cover Right Size 04 (478/ 482)	N007R04	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 12 (478/ 482)	N007R12	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Lateral Leg Positioner	EL800	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Left Size 2	478L02	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 07 (475/ 503)	N008L07	EUDAMED	Class I	Active
Symphony Size 5	508 05	EUDAMEDFDA UDI	Class I	Active
Relax Gelcell G2 Cover Size 18x18inch	GC005-1818	EUDAMEDFDA UDI	Class I	Active
Tropez Size 14	641 14	EUDAMEDFDA UDI	Class I	Active
Relax Trio Cushion Cover Size 17x17inch	TC001-1717	EUDAMEDFDA UDI	Class I	Active
Azure Crutch Stirrups	AZ410	EUDAMEDFDA UDI	Class I	Active
Wrap Around Hinged Knee Supp Large	CK-PT12404	EUDAMED	Class I	Active
Breastform Cover Left Size 09 (478/ 482)	N007L09	EUDAMEDFDA UDI	Class I	Active
Relax Gelcell Cover Size 15x14inch	GC004-1514	EUDAMEDFDA UDI	Class I	Active
Luna Right Size 6	622 06R	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Right Size 9	62309R	EUDAMED	Class I	Active
Luna Right Size 10	622 10R	EUDAMEDFDA UDI	Class I	Active
A Supreme Right Size 2	503 2R	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Bronze Size 05	625 05	EUDAMED	Class I	Active
Relax Duogel Mesh Cover Size 17x18inch	DC009-1718	EUDAMEDFDA UDI	Class I	Active
Duogel Wipeable Cover Size 20x20inch	DWC003-2020	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 13 (101/471/472/476/481/490/495/571/701)	N00113	EUDAMED	Class I	Active
Breastform Cover Size 12 (102/483)	D00112	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 9	478R09	EUDAMEDFDA UDI	Class I	Active
Tropez Size 3	641 03	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