HomeUnited Kingdom of Great Britain and Northern IrelandGenesis Diagnostics , Ltd.

Genesis Diagnostics , Ltd.

United Kingdom of Great Britain and Northern Ireland · Littleport
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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
pendingnot queried
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
6active device licences
Class II 6
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
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.

United States0 registration records, 1 510(k), 0 PMA, 30 excluded
Brazil1 confirmed, 4 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada6 confirmed, 2 excluded
Manufacturer names merged into this page: GENESIS DIAGNOSTICS LTD. · GENESIS DIAGNOSTICS LTD

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Littleport

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
GENESIS DIAGNOSTICS LIMITED
Company number
02924988
Registration status
Active
Legal form
Private Limited Company
Incorporated
1994-05-03
Principal activity
99999 - Dormant Company
Registered address
EDEN RESEARCH PARK, LITTLEPORT, CB6 1SE

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

FDA 510(k) clearances by year

11999 · K973910

Registration details (sample)

MarketIdentifierNameClass / date
USK973910GLIADIN ANTIBODIES ELISA1999-02-17
BR10350840184GENARRAYT MICROARRAY SYSTEMClass II
CA26875HP-G SCREEN H PYLORI (IGG) ANTIBODIES (ELISA)Class II
CA26876ANTI-GBM (GLOMERULAR BASEMENT MEMBRANE) ANTIBODIES (ELISA) KITClass II
CA26877ANTI-PR3 ANTIBODIES (ELISA) KIT (SERINE PROTEASE-3)Class II

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