Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043494619

FEI Number

3043494619

Entity Name

TOPIA MEDTECH LIMITED

City/State/Country

Welwyn Garden City Herefordshire, GB

Establishment Address

2 Falcon Gate,, Shire Park,, Welwyn Garden City Herefordshire AL7 1TW, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Topia MedTech Limited (Owner Number: 10094979)

Owner / Operator Contact Address

14 Havelock Place (MS), London, GB-HRW HA11LJ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252670

PMA Number

N/A

All Registered Proprietary Names

Alzevita

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-01-12

Official Correspondent

Kamlesh Patel

US Agent Details

Mary Gunn Email: mary.gunn@topiamedtech.com Phone: (805) 6278120

Related Public Records

Same Entity

Topia MedTech Limited

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043494619. Last updated year: 2026. Please use registration number 3043494619 when referencing this establishment in official correspondence.