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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 5 of 22

Device	Model / Reference	Registries	Class	Status
Relax Duogel Cushion Size 14x14inch	RD003-1414	EUDAMEDFDA UDI	Class I	Active
Duo-Profile With Mesh/Spacer Cover Size 17x16inch	RDP009-1716	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 16x20inch	RD003-1620	EUDAMEDFDA UDI	Class I	Active
Impressions II Encore Size 8	102 08	EUDAMEDFDA UDI	Class I	Active
Relax Duogel Cushion Size 19x18inch	RD003-1918	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Open Head Ring, Adult	EL022	EUDAMEDFDA UDI	Class I	Active
Re-Cover Shell Size Large	822L	EUDAMEDFDA UDI	Class I	Active
Neoform Wrist Thumb Brace Xl/Rt	CK-NWT-05R	EUDAMED	Class I	Active
Oasis Head Section	OA036	EUDAMED	Class I	Active
Relax GelCell Cushion Size 18x18inch	RG004-1818	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 10	616 10	EUDAMEDFDA UDI	Class I	Active
BodiCool Wave Triangle Size 4	495 04	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 10 (151)	N00210	EUDAMED	Class I	Active
Duogel Wipeable Cover Size 18x16inch	DWC003-1816	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Right Size 3	62303R	EUDAMED	Class I	Active
Silk Teardrop Size 2	473 02	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Armboard Pad	EL070	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Left Size 14	478L14	EUDAMEDFDA UDI	Class I	Active
Silk Xtend Right Size 2	478R02	EUDAMEDFDA UDI	Class I	Active
Cara Size 9	153 09	EUDAMEDFDA UDI	Class I	Active
Duo-Profile With Standard Black Cover Size 20x18inch	RDP003-2018	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Left Size 7	62307L	EUDAMED	Class I	Active
Breastform Cover Size 03 (151)	N00203	EUDAMED	Class I	Active
Re-Cover Shell Size Medium	822M	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 3	616 03	EUDAMEDFDA UDI	Class I	Active
Oasis Heel Cups (x2)	OA131-2	EUDAMEDFDA UDI	Class I	Active
Relax GelCell G2 Cushion Size 18x16inch	RG005-1816	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Bronze Size 08	625 08	EUDAMED	Class I	Active
Symphony Size 3	508 03	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 10	483 10	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 4	483 04	EUDAMEDFDA UDI	Class I	Active
E Supreme Size 12	509 12	EUDAMEDFDA UDI	Class I	Active
Silk Encore Triangle Size 9	483 09	EUDAMEDFDA UDI	Class I	Active
Tri Featherwieight Size 9	616 09	EUDAMEDFDA UDI	Class I	Active
Silk A Supreme Left Size 6	475L06	EUDAMEDFDA UDI	Class I	Active
Breastform Cover Size 04 (151)	N00204	EUDAMED	Class I	Active
Assymetrical Left Size 6	498 06L	EUDAMED	Class I	Active
Silk Triangle Size 6	471 06	EUDAMEDFDA UDI	Class I	Active
Luna Left Size 3	622 03L	EUDAMEDFDA UDI	Class I	Active
Luna Triangle Bronze Size 11	625 11	EUDAMED	Class I	Active
A Supreme Left Size 8	503 8L	EUDAMEDFDA UDI	Class I	Active
Trulife Pk 6 Lge/Rt Classic Wrist Br	CK-FTC-04R	EUDAMED	Class I	Active
Silk A Supreme Left Size 1	475L01	EUDAMEDFDA UDI	Class I	Active
Azure Arm Protector (Long)	AZ201	EUDAMEDFDA UDI	Class I	Active
Oasis Elite Prone Head Rest, Adult	EL141	EUDAMEDFDA UDI	Class I	Active
Triangular Partial Size 9	533 09	EUDAMEDFDA UDI	Class I	Active
Teardrop Partial Encore Size 5	356 05	EUDAMEDFDA UDI	Class I	Active
Partial Size 11	531 11	EUDAMED	Class I	Active
Silk Flex Size 4	477 04	EUDAMEDFDA UDI	Class I	Active
Luna Bronze Right Size 4	62304R	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

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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