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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 20 of 22

Device	Model / Reference	Registries	Class	Status
A Supreme Right Size 1	503 1R	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 13 (475/ 503)	N008R13	EUDAMED	Class I	Active
Relax Easy Cushion Size 18x16inch	RE005-1816	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 06 (485/ 153)	N00306	EUDAMEDFDA UDI	Class I	Active
Relax GelCell G2 Cushion Size 16x16inch	RG005-1616	EUDAMEDFDA UDI	Class I	Active
Silk Flex Darktone Size 02	487 02	EUDAMED	Class I	Active
Breastform Cover Left Size 14 (475/ 503)	N008L14	EUDAMED	Class I	Active
Oasis Armboard Pads	OA072	EUDAMEDFDA UDI	Class I	Active
Silk Teardrop Size 1	473 01	EUDAMEDFDA UDI	Class I	Active
Silk Curve Size 10	485 10	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 14	616 14	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 15x17inch	DC009-1517	EUDAMEDFDA UDI	Class I	Active
Impressions II Encore Size 10	102 10	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 1	475R01	EUDAMEDFDA UDI	Class I	Active
Triangular Partial Size 3	533 03	EUDAMEDFDA UDI	Class I	Active
Azure Heel Protector	AZ401	EUDAMEDFDA UDI	Class I	Active
Tri Partial Encore Size 9	535 09	EUDAMEDFDA UDI	Class I	Active
Silk Teardrop Size 3	473 03	EUDAMEDFDA UDI	Class I	Active
Luna Right Size 3	622 03R	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 13 (485/ 153)	N00313	EUDAMEDFDA UDI	Class I	Active
Duette Triangle Size 7	701 07	EUDAMED	Class I	Active
Neoform Wrist Thumb Brace Lge/Lt	CK-NWT-04L	EUDAMED	Class I	Active
Relax Easy High Profile Wipedown Black Outer Cover Size 17x17inch	ECH005-1717	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Bronze Size 03	625 03	EUDAMED	Class I	Active
Breastform Cover Right Size 10 (478/ 482)	N007R10	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Right Size 3	497 03R	EUDAMED	Class I	Active
Breastform Cover Left Size 08 (475/ 503)	N008L08	EUDAMED	Class I	Active
Impressions II Size 4	101 04	EUDAMEDFDA UDI	Class I	Active
Bella Size 7	571 07	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 15x14inch	RD003-1514	EUDAMEDFDA UDI	Class I	Active
Relax Easy High Profile Wipedown Black Outer Cover Size 20x20inch	ECH005-2020	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 17x20inch	RD003-1720	EUDAMEDFDA UDI	Class I	Active
Silk Teardrop Size 6	473 06	EUDAMEDFDA UDI	Class I	Active
Trulife Pk 6 Med/Lt Classic Wrist Br	CK-FTC-03L	EUDAMED	Class I	Active
Paediatric Chest Roll, Medium	OA209	EUDAMED	Class I	Active
Azure Table Pad (3/4 length)	AZ611	EUDAMEDFDA UDI	Class I	Active
Azure Table Pad (short)	AZ610	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Closed Head Ring, Adult	EL012	EUDAMEDFDA UDI	Class I	Active
Tri Partial Encore Size 3	535 03	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 13	478R13	EUDAMEDFDA UDI	Class I	Active
Incline Headrest	ELP801	EUDAMED	Class I	Active
Luna Right Size 7	622 07R	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Right Size 4	475R04	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 15 (102/483)	D00115	EUDAMEDFDA UDI	Class I	Active
Pavlik Harness White With Bootees Small	CK-T871602	EUDAMED	Class I	Active
Luna Triangle Beige Size 10	624 10	EUDAMED	Class I	Active
Oasis + Head and Neck Support	OP151	EUDAMEDFDA UDI	Class I	Active
Trulife Pk 6 Sml/Rt Classic Wrist Br	CK-FTC-02R	EUDAMED	Class I	Active
Breastform Cover Left Size 01 (478/ 482)	N007L01	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 17 (473/ 509)	N00517	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