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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 17 of 22

Device	Model / Reference	Registries	Class	Status
Silk Teardrop Size 11	473 11	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 12 (151)	N00212	EUDAMED	Class I	Active
Relax Duogel Cushion Size 15x18inch	RD003-1518	EUDAMEDFDA UDI	Class I	Active
Duo-Profile With Mesh/Spacer Cover Size 18x16inch	RDP009-1816	EUDAMEDFDA UDI	Class I	Active
Impressions II Size 2	101 02	EUDAMEDFDA UDI	Class I	Active
Silk Flex Darktone Size 08	487 08	EUDAMED	Class I	Active
Elite Trendelenburg System 40°	ELTS40	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 07 (477)	N00607	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 02 (497/498)	N009R02	EUDAMED	Class I	Active
Luna Triangle Beige Size 13	624 13	EUDAMED	Class I	Active
Wrap Around Hinged Knee Supp Small	CK-PT12402	EUDAMED	Class I	Active
Silk Curve Size 4	485 04	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Middle Left Section / Middle Right Section	EL908	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 06 (497/498)	N009L06	EUDAMED	Class I	Active
Relax Duogel With Wipeable Cover Size 24x18inch	RD006-2418	EUDAMEDFDA UDI	Class I	Active
Trulife Pk 6 Med/Rt Classic Wrist Br	CK-FTC-03R	EUDAMED	Class I	Active
Teardrop Silk Lite Partial Beige Size 9	536 09	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Size 5	471 05	EUDAMEDFDA UDI	Class I	Active
Trulife Clavicle Splint Medium	CK-CLA-05	EUDAMED	Class I	Active
Cara Size 10	153 10	EUDAMEDFDA UDI	Class I	Active
Duo=Profile With Wipeable Cover Size 16x16inch	RDP006-1616	EUDAMEDFDA UDI	Class I	Active
Silk Flex Size 3	477 03	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 04 (475/ 503)	N008R04	EUDAMED	Class I	Active
Cara Size 8	153 08	EUDAMEDFDA UDI	Class I	Active
A Supreme Right Size 7	503 7R	EUDAMEDFDA UDI	Class I	Active
Oasis Armboard Pads	OA071	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 05 (475/ 503)	N008L05	EUDAMED	Class I	Active
Silk Triangle Size 15	471 15	EUDAMED	Class I	Active
Trulife Pk 6 Lge/Lt Classic Wrist Br	CK-FTC-04L	EUDAMED	Class I	Active
Assymetrical Left Size 2	498 02L	EUDAMED	Class I	Active
Oasis Closed Head Ring Adolescent	OA011	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Supine Head Rest	EL151	EUDAMEDFDA UDI	Class I	Active
Triangular Partial Size 7	533 07	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 04 (477)	N00604	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 19x20inch	RD003-1920	EUDAMEDFDA UDI	Class I	Active
Azure Leg Protector	AZ400	EUDAMEDFDA UDI	Class I	Active
Assymetrical Left Size 4	498 04L	EUDAMED	Class I	Active
Tri Partial Encore Size 5	535 05	EUDAMEDFDA UDI	Class I	Active
Luna Right Size 9	622 09R	EUDAMEDFDA UDI	Class I	Active
A Supreme Left Size 4	503 4L	EUDAMEDFDA UDI	Class I	Active
Duo-Profile With Standard Black Cover Size 18x18inch	RDP003-1818	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 20x16inch	DC009-2016	EUDAMEDFDA UDI	Class I	Active
Relax Easy High Profile Cushion Size 18x20inch	REH005-1820	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Plus Size 2	472 02	EUDAMEDFDA UDI	Class I	Active
Relax Wipedown Easy Cushion Cover Size 14x18inch	EC004-1418	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 03 (475/ 503)	N008R03	EUDAMED	Class I	Active
Relax Gelcell Cover Size 16x16inch	GC004-1616	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 15	495 15	EUDAMEDFDA UDI	Class I	Active
Duogel Standard Black Cover Size 17x20inch	DC003-1720	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Upper Right Section / Lower left Section	EL907	EUDAMEDFDA UDI	Class I	Active

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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