Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003747162

FEI Number

3003747162

Entity Name

GENIAL HELIX LTD

City/State/Country

Chester Flintshire, GB

Establishment Address

Office 19, CoWorkz Business Centre, Chester Flintshire CH1 4QL, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Genial Helix Ltd (Owner Number: 10060260)

Owner / Operator Contact Address

Office 19, CoWorkz Business Centre, Chester, GB-FLN CH1 4QL, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Skin Growth Supplement Solid Tumour Growth Supplement Product of Conception Growth Supplement Lymphocyte Growth Supplement Erythrocyte Lysis Solution Cytoclear Optimal Hypotonic Solution Metaphase Arresting Solution Anti-Clotting Reagent Buffered Hypotonic Solution Pre-Hypotonic Solution Chromosome Resolution Additive Bone Marrow Growth Supplement Lymphoma Growth Supplement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2019-04-17

Official Correspondent

Lawrence Crees

US Agent Details

Peter Mousseau Business: Rainbow Scientific, Inc Email: pmousseau@rainbowscientific.com Phone: (860) 2988382

Related Public Records

Same Entity

Genial Helix Ltd

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 3003747162. Last updated year: 2026. Please use registration number 3003747162 when referencing this establishment in official correspondence.