Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021864

FEI Number

3007529805

Entity Name

HTZ Ltd

City/State/Country

East Grinsted West Sussex, GB

Establishment Address

Unit 4 The Felbridge Centre, Imberhorne Lane, East Grinsted West Sussex RH19 1XP, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HTZ Ltd (Owner Number: 8021864)

Owner / Operator Contact Address

Unit 4, The Felbridge Centre, Imberhorne Lane, East Grinstead, GB-WSX RH19 1XP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AFT3100 AFT5000 BEELINE ZX AFT3200 AFT5000I

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2002-04-25

Official Correspondent

kam keung Tse

US Agent Details

Cayce Horner Business: Global Focus Marketing & Distribution Email: cayce.horner@gfmd.com Phone: (817) 9918778

Related Public Records

Same Entity

HTZ Ltd

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
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

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3016068451	LABTURBO BIOTECH CORPORATION	Taipei, TW
3007118747	EUROIMMUN US INC.	Mountain Lakes, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021864. Last updated year: 2026. Please use registration number 8021864 when referencing this establishment in official correspondence.