Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027557347

FEI Number

3027557347

Entity Name

GT Diagnostics (UK) Limited

City/State/Country

Aberdeen Aberdeen City, GB

Establishment Address

395 King Street, Aberdeen Aberdeen City AB24 5RP, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Genting TauRx Diagnostic Centre Sdn Bhd (Owner Number: 10088348)

Owner / Operator Contact Address

14th Floor, Wisma Genting, Jalan Sultan Ismail, Kuala Lumpur, MY-14 50250, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HiPAL Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTY	Computerized Cognitive Assessment Aid, Exempt	Neurology	Class 2	882.1470	2023-07-05

Official Correspondent

No official correspondent registered.

US Agent Details

Lindsey Howard Business: Ideagen, Incorporated DBA/CompliancePath LLC Email: lhoward@compliancepath.com Phone: (240) 2047621

Related Public Records

Same Entity

Genting TauRx Diagnostic Centre Sdn Bhd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027557347. Last updated year: 2026. Please use registration number 3027557347 when referencing this establishment in official correspondence.