Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020869

FEI Number

5714

Entity Name

TRULIFE LTD.

City/State/Country

DUBLIN 24, IE

Establishment Address

AIRTON ROAD, TALLAGHT, DUBLIN 24 --, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Trulife (Owner Number: 8020869)

Owner / Operator Contact Address

Airton Road, Tallaght, Dublin 24, IE-NOTA --, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pressurecare Breastcare Relax

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JZR	Support Gels	Immunology	Class 1	866.4900	1997-09-26
NOJ	Prosthesis, Breast, External, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2014-01-06
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2001-08-24

Official Correspondent

Rebecca Holmes

US Agent Details

Mike Sumner Business: Trulife, Inc. Email: msumner@trulife.com Phone: (360) 5988996

Related Public Records

Same Entity

Trulife

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006979871	TRULIFE, LTD.	S. Yorkshire Sheffield, GB

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3004967086	Ortho Pauher Ind. Com. E Dist. Ltda	Recife Pernambuco, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020869. Last updated year: 2026. Please use registration number 8020869 when referencing this establishment in official correspondence.