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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 6 of 22

Device	Model / Reference	Registries	Class	Status
Silk Triangle Plus Size 9	472 09	EUDAMEDFDA UDI	Class I	Active
Relax Duogel With Wipeable Cover Size 17x17inch	RD006-1717	EUDAMEDFDA UDI	Class I	Active
Impressions II Size 12	101 12	EUDAMEDFDA UDI	Class I	Active
Silk Flex Size 2	477 02	EUDAMEDFDA UDI	Class I	Active
Relax GelCell G2 Cushion Size 18x18inch	RG005-1818	EUDAMEDFDA UDI	Class I	Active
Assymetrical Right Size 8	498 08R	EUDAMED	Class I	Active
Silk A Supreme Left Size 3	475L03	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 08 (478/ 482)	N007L08	EUDAMEDFDA UDI	Class I	Active
Relax Easy Cushion Size 16x16inch	RE005-1616	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Beige Size 17	624 17	EUDAMED	Class I	Active
Duogel Standard Black Cover Size 19x18inch	DC003-1918	EUDAMEDFDA UDI	Class I	Active
Assymetrical Right Size 2	498 02R	EUDAMED	Class I	Active
Nelo Universal Positioner Medium	NE200	EUDAMED	Class I	Active
ET L-Bracket (Pair)	ELT23	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 10 (497/498)	N009L10	EUDAMED	Class I	Active
Luna Bronze Right Size 11	62311R	EUDAMED	Class I	Active
Breastform Cover Size 11 (477)	N00611	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 4	616 04	EUDAMEDFDA UDI	Class I	Active
Sublime Arís Size 5	151 05	EUDAMEDFDA UDI	Class I	Active
Silk Connect Size 3	476 03	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 19x20inch	DC009-1920	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 18x20inch	DC009-1820	EUDAMEDFDA UDI	Class I	Active
Impressions II Encore Size 4	102 04	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 16x16inch	DC009-1616	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 14	475R14	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 2	475R02	EUDAMEDFDA UDI	Class I	Active
Silk Curve Size 6	485 06	EUDAMEDFDA UDI	Class I	Active
Silk Ultima Triangle Size 3	481 03	EUDAMEDFDA UDI	Class I	Active
Tri Partial Encore Size 8	535 08	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 14	701 14	EUDAMED	Class I	Active
Relax Duogel Cushion Size 17x19inch	RD003-1719	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Left Size 11	478L11	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 04 (478/ 482)	N007L04	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 13 (477)	N00613	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 2 (101/471/472/476/481/490/495/571/701)	N00102	EUDAMED	Class I	Active
Re-Cover Shell Size Extra Large	822XL	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Left Size 4	62304L	EUDAMED	Class I	Active
Impressions II Size 10	101 10	EUDAMEDFDA UDI	Class I	Active
Triangle Silk Lite Partial Beige Size 7	538 07	EUDAMEDFDA UDI	Class I	Active
E Supreme Size 5	509 05	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 15	483 15	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Left Size 01 (475/ 503)	N008L01	EUDAMED	Class I	Active
Breastform Cover Size 01 (508)	N00401	EUDAMED	Class I	Active
Bella Size 9	571 09	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 7	478R07	EUDAMEDFDA UDI	Class I	Active
A Supreme Left Size 3	503 3L	EUDAMEDFDA UDI	Class I	Active
Triangle Silk Lite Partials Dark Tone Size 5	539 05	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 2	701 02	EUDAMED	Class I	Active
Symphony Size 14	508 14	EUDAMEDFDA UDI	Class I	Active
Oasis + Disc (10 disc per box)	OP015	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