Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007673896

FEI Number

3007673896

Entity Name

JALTEK SYSTEMS LIMITED

City/State/Country

Luton, GB

Establishment Address

Unit 13 Sundon Business park, Dencora way, Luton LU3 3HP, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

JALTEK SYSTEMS LIMITED (Owner Number: 10090546)

Owner / Operator Contact Address

Unit 13 Sundon Business Park, Dencora Way, Luton, GB-LUT LU3 3HP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HENSON 9000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	Class 1	886.1605	2024-04-11

Official Correspondent

No official correspondent registered.

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

JALTEK SYSTEMS LIMITED

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 3007673896. Last updated year: 2026. Please use registration number 3007673896 when referencing this establishment in official correspondence.