Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011801330

FEI Number

3011801330

Entity Name

NEWMARKET BIOMEDICAL LTD

City/State/Country

Kentford Suffolk, GB

Establishment Address

Unit 1, Lanwades Business Park, Kentford Suffolk CB8 7PN, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Newmarket Biomedical Ltd (Owner Number: 10061491)

Owner / Operator Contact Address

Unit 1, Lanwades Business Park, Kentford, GB-SFK CB8 7PN, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK180301

PMA Number

N/A

All Registered Proprietary Names

PK7400 TP HA CONTROLS PK7400 TP HA REAGENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MYR	Test, Donor, Syphilis, Antigens, Treponemal	Microbiology	Class 2	866.3830	2019-10-23

Official Correspondent

Mark Bates

US Agent Details

Maureen Garner Business: New World Regulatory Solutions Inc Email: NWRSinc@gmail.com Phone: (732) 7797422

Related Public Records

Same Entity

Newmarket Biomedical 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 3011801330. Last updated year: 2026. Please use registration number 3011801330 when referencing this establishment in official correspondence.