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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 7 of 22

Device	Model / Reference	Registries	Class	Status
Silk Connect Size 10	476 10	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Size 11	471 11	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Bronze Size 16	625 16	EUDAMED	Class I	Active
E Supreme Size 9	509 09	EUDAMEDFDA UDI	Class I	Active
Teardrop Silk Lite Partials Dark Tone Size 9	537 09	EUDAMEDFDA UDI	Class I	Active
Relax Easy Cushion Size 18x18inch	RE005-1818	EUDAMEDFDA UDI	Class I	Active
Partial Size 12	531 12	EUDAMED	Class I	Active
Silk Xtend Right Size 11	478R11	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 14 (102/483)	D00114	EUDAMEDFDA UDI	Class I	Active
Silk Connect Size 9	476 09	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 07 (497/498)	N009R07	EUDAMED	Class I	Active
Symphony Size 2	508 02	EUDAMEDFDA UDI	Class I	Active
Duogel Wipeable Cover Size 17x19inch	DWC003-1719	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 11	616 11	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 13 (508)	N00413	EUDAMED	Class I	Active
Silk Ultima Triangle Size 8	481 08	EUDAMEDFDA UDI	Class I	Active
Relax Duogel With Wipeable Cover Size 15x14inch	RD006-1514	EUDAMEDFDA UDI	Class I	Active
BodiCool Assymetrical Left Size 9	497 09L	EUDAMED	Class I	Active
Oasis Heel Cups Box of 36	OA131-36	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 9	495 09	EUDAMEDFDA UDI	Class I	Active
Silk Triangle Size 17	471 17	EUDAMED	Class I	Active
E Supreme Size 17	509 17	EUDAMEDFDA UDI	Class I	Active
Symphony Size 9	508 09	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Right Size 07 (475/ 503)	N008R07	EUDAMED	Class I	Active
Oasis Torso Section	OA037	EUDAMEDFDA UDI	Class I	Active
Pre-Op Glove	POG-001	EUDAMED	Class I	Active
Breastform Cover Right Size 06 (475/ 503)	N008R06	EUDAMED	Class I	Active
A Supreme Right Size 11	503 11R	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Arm/Knee Pad Small	EL402	EUDAMEDFDA UDI	Class I	Active
Impressions II Encore Size 12	102 12	EUDAMEDFDA UDI	Class I	Active
Silk Ultima Triangle Size 14	481 14	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 14 (508)	N00414	EUDAMED	Class I	Active
Oasis Open Head Ring Paediatric	OA020	EUDAMEDFDA UDI	Class I	Active
Symphony Size 12	508 12	EUDAMEDFDA UDI	Class I	Active
Featherweight Size 15	615 15	EUDAMEDFDA UDI	Class I	Active
Trulife Clavicle Splint Large	CK-CLA-07	EUDAMED	Class I	Active
Breastform Cover Size 07 (508)	N00407	EUDAMED	Class I	Active
Breastform Cover Size 05 (473/ 509)	N00505	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Mesh Cover Size 15x14inch	DC009-1514	EUDAMEDFDA UDI	Class I	Active
Oasis Universal Patient Positioners	OA052	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 10 (102/483)	D00110	EUDAMEDFDA UDI	Class I	Active
ET Arm Retainer (Pair)	ELT22	EUDAMEDFDA UDI	Class I	Active
Nelo Universal Positioner Small	NE100	EUDAMED	Class I	Active
Breastform Cover Size 14 (151)	N00214	EUDAMED	Class I	Active
Duette Triangle Size 5	701 05	EUDAMED	Class I	Active
Symphony Size 10	508 10	EUDAMEDFDA UDI	Class I	Active
Oasis Flat Bottom Chest Roll	OA213	EUDAMED	Class I	Active
A Supreme Right Size 5	503 5R	EUDAMEDFDA UDI	Class I	Active
Luna Left Size 11	622 11L	EUDAMEDFDA UDI	Class I	Active
Relax Gelcell Cover Size 18x18inch	GC004-1818	EUDAMEDFDA UDI	Class I	Active

Related Companies

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Authorities

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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