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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 10 of 22

Device	Model / Reference	Registries	Class	Status
Silk Ultima Triangle Size 7	481 07	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 18x16inch	RD003-1816	EUDAMEDFDA UDI	Class I	Active
Silk Curve Size 9	485 09	EUDAMEDFDA UDI	Class I	Active
A Supreme Right Size 13	503 13R	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 07	624 07	EUDAMED	Class I	Active
Breastform Cover Size 16 (101/471/472/476/481/490/495/571/701)	N00116	EUDAMED	Class I	Active
Breastform Cover Left Size 09 (497/498)	N009L09	EUDAMED	Class I	Active
Breastform Cover Size 12 (101/471/472/476/481/490/495/571/701)	N00112	EUDAMED	Class I	Active
Pavlik Harness White No Bootees L	CK-T871204	EUDAMED	Class I	Active
Impressions II Size 5	101 05	EUDAMEDFDA UDI	Class I	Active
Luna Left Size 4	622 04L	EUDAMEDFDA UDI	Class I	Active
Neoform Wrist Thumb Brace Xs/Lt	CK-NWT-01L	EUDAMED	Class I	Active
Oasis Ulnar/Brachial Nerve Protector Full Length	OA062	EUDAMED	Class I	Active
Silk Flex Darktone Size 14	487 14	EUDAMED	Class I	Active
Silk Ultima Triangle Size 1	481 01	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 6	495 06	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 4	701 04	EUDAMED	Class I	Active
Silk A Supreme Left Size 11	475L11	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Bronze Size 04	625 04	EUDAMED	Class I	Active
Breastform Cover Right Size 02 (478/ 482)	N007R02	EUDAMEDFDA UDI	Class I	Active
Triangle Silk Lite Partial Beige Size 8	538 08	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 16x20inch	DC009-1620	EUDAMEDFDA UDI	Class I	Active
ET Anti Slip Mat	ELT015	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Plus Size 12	472 12	EUDAMEDFDA UDI	Class I	Active
Pavlik Harness White With Bootees Medium	CK-T871603	EUDAMED	Class I	Active
Neoform Wrist Thumb Brace Xl/Lt	CK-NWT-05L	EUDAMED	Class I	Active
Silk Encore Triangle Size 5	483 05	EUDAMEDFDA UDI	Class I	Active
Tri Leisureform Size 6	611 06	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 3	483 03	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Left Size 8	497 08L	EUDAMED	Class I	Active
Featherweight Size 14	615 14	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 13	701 13	EUDAMED	Class I	Active
BodiCool Wave Triangle Size 8	495 08	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 10 (101/471/472/476/481/490/495/571/701)	N00110	EUDAMED	Class I	Active
Pavlik Harness White With Bootees Xxsmall	CK-T871600	EUDAMED	Class I	Active
Breastform Cover Left Size 02 (475/ 503)	N008L02	EUDAMED	Class I	Active
Silk Triangle Plus Size 13	472 13	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 7	483 07	EUDAMEDFDA UDI	Class I	Active
Assymetrical Right Size 4	498 04R	EUDAMED	Class I	Active
Breastform Cover Size 09 (485/ 153)	N00309	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Bronze Size 07	625 07	EUDAMED	Class I	Active
Relax Duogel Cushion Size 22x18inch	RD003-2218	EUDAMEDFDA UDI	Class I	Active
Relax Trio Cushion Size 17x17inch	RT001-1717	EUDAMEDFDA UDI	Class I	Active
Silk Flex Size 6	477 06	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Bronze Size 14	625 14	EUDAMED	Class I	Active
Teardrop Silk Lite Partials Dark Tone Size 5	537 05	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 18x18inch	RD003-1818	EUDAMEDFDA UDI	Class I	Active
Teardrop Silk Lite Partials Dark Tone Size 3	537 03	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 08 (497/498)	N009R08	EUDAMED	Class I	Active
Breastform Cover Size 03 (473/ 509)	N00503	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