HomeUnited Kingdom of Great Britain and Northern IrelandNewmarket Biomedical Ltd

Newmarket Biomedical Ltd

United Kingdom of Great Britain and Northern Ireland · Newmarket · www.new-bio.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN GB-MF-000025155

This company has registrations in European Union, United States, United Kingdom, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
10UDI-DI device records
IVD C 7IVD general 3
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
5registered device records
IVD C 2IVD general 3
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 3 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
2active registrations
Class 2b 2
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union10 raw hits, 0 excluded, 10 confirmed
United States1 registration records, 0 510(k), 0 PMA, 1 excluded
United Kingdom5 confirmed, 0 excluded
Manufacturer names merged into this page: NEWMARKET BIOMEDICAL LTD

Regulatory identity

EU manufacturer SRN
GB-MF-000025155
EU authorised representative
MDSS GmbH

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Newmarket
Website
www.new-bio.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassaysMicrobiology & infectious disease diagnostics

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
NEWMARKET BIOMEDICAL LIMITED
Company number
07500738
Registration status
Active
Legal form
Private Limited Company
Incorporated
2011-01-21
Principal activity
72110 - Research and experimental development on biotechnology / 74909 - Other professional, scientific and technical ac
Registered address
UNIT 1, KENTFORD, CB8 7PN

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

Test, Donor, Syphilis, Antigens, Treponemal 1

Registration details (sample)

MarketIdentifierNameClass / date
EU05060515140108NewBio Syphilis EIA TA - 96 Test KitIVD general
EU05060515140047PK7400 TP HA ControlsIVD general
EU05060515140030PK7400 TP HA ReagentIVD general
EU05060515140092Newbio TPHA 1000IVD C
UK51817PK7400 TP HA CONTROLSIVD general
UK61225pK7400 TP HA ReagentIVD general
UK61225Newbio TPHA 100IVD C

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