Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009736003

FEI Number

3009736003

Entity Name

Helena Laboratories UK Ltd

City/State/Country

Gateshead Newcastle upon Tyne, GB

Establishment Address

Queensway South, Team Valley Trading Estate, Gateshead Newcastle upon Tyne NE11 0SD, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Helena Biosciences Europe (Owner Number: 10041365)

Owner / Operator Contact Address

Queensway South, Team Valley Trading Estate, Gateshead, GB-GAT NE11 0SD, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111369

PMA Number

N/A

All Registered Proprietary Names

V8 Immunodisplacement Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2012-07-17

Official Correspondent

Ben Johnson

US Agent Details

Rachel Easley Business: Director of Regulatory Affairs Email: reasley@helena.com Phone: (409) 8423714

Related Public Records

Same Entity

Helena Biosciences Europe

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

View Entity Profile →

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3012924127	Prince Technologies B.V.	Emmen Drenthe, NL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009736003. Last updated year: 2026. Please use registration number 3009736003 when referencing this establishment in official correspondence.