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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 4 of 22

Device	Model / Reference	Registries	Class	Status
Silk Flex Size 7	477 07	EUDAMEDFDA UDI	Class I	Active
Neoform Wrist Thumb Brace Sml/Rt	CK-NWT-02R	EUDAMED	Class I	Active
Breastform Cover Left Size 03 (478/ 482)	N007L03	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Size 4	471 04	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Left Size 9	475L09	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 06 (497/498)	N009R06	EUDAMED	Class I	Active
Breastform Cover Right Size 09 (475/ 503)	N008R09	EUDAMED	Class I	Active
Relax Duogel Cushion Size 20x20inch	RD003-2020	EUDAMEDFDA UDI	Class I	Active
Duo=Profile With Wipeable Cover Size 20x18inch	RDP006-2018	EUDAMED	Class I	Active
Silk Teardrop Size 14	473 14	EUDAMEDFDA UDI	Class I	Active
Azure Sacral Protector Large	AZ301	EUDAMEDFDA UDI	Class I	Active
Oasis Crutch Stirrup Pads (x2)	OA090	EUDAMEDFDA UDI	Class I	Active
Luna Left Size 8	622 08L	EUDAMEDFDA UDI	Class I	Active
Bella Size 14	571 14	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Prone Positioning System	EL905	EUDAMEDFDA UDI	Class I	Active
Teardrop Silk Lite Partial Beige Size 6	536 06	EUDAMEDFDA UDI	Class I	Active
Relax Trio Cushion Cover Size 18x18inch	TC001-1818	EUDAMEDFDA UDI	Class I	Active
Tri Partial Encore Size 7	535 07	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 13	616 13	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 7 (102/483)	D00107	EUDAMEDFDA UDI	Class I	Active
Cara Size 12	153 12	EUDAMEDFDA UDI	Class I	Active
Duogel Wipeable Cover Size 14x14inch	DWC003-1414	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Left Size 7	497 07L	EUDAMED	Class I	Active
Luna Bronze Right Size 6	62306R	EUDAMED	Class I	Active
Relax GelCell Cushion Size 16x16inch	RG004-1616	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 1	495 01	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 14 (475/ 503)	N008R14	EUDAMED	Class I	Active
Oasis Universal Profile Pad	OA041	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 12 (473/ 509)	N00512	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Size 14	471 14	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 3 (101/471/472/476/481/490/495/571/701)	N00103	EUDAMED	Class I	Active
Bella Size 13	571 13	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 4 (101/471/472/476/481/490/495/571/701)	N00104	EUDAMED	Class I	Active
Trendelenburg Headrest	TR012	EUDAMEDFDA UDI	Class I	Active
Sublime Arís Size 7	151 07	EUDAMEDFDA UDI	Class I	Active
Silk Flex Size 11	477 11	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 03 (485/ 153)	N00303	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 03	624 03	EUDAMED	Class I	Active
Oasis Elite Closed Head Ring, Adolescent	EL011	EUDAMEDFDA UDI	Class I	Active
Silk Teardrop Size 5	473 05	EUDAMEDFDA UDI	Class I	Active
A Supreme Left Size 12	503 12L	EUDAMEDFDA UDI	Class I	Active
Duogel Standard Black Cover Size 20x16inch	DC003-2016	EUDAMEDFDA UDI	Class I	Active
Relax Wipedown Easy Cushion Cover Size 18x18inch	EC004-1818	EUDAMEDFDA UDI	Class I	Active
Teardrop Partial Encore Size 3	356 03	EUDAMEDFDA UDI	Class I	Active
Trulife Pk 6 Xs/Lt Classic Wrist Br	CK-FTC-01L	EUDAMED	Class I	Active
Breastform Cover Size 10 (477)	N00610	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 02 (485/ 153)	N00302	EUDAMEDFDA UDI	Class I	Active
Duo-Profile With Mesh/Spacer Cover Size 16x18inch	RDP009-1618	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 3	495 03	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Flat Bottom Chest Roll	EL218	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