HomeUnited Kingdom of Great Britain and Northern IrelandBIO-DIAGNOSTICS LTD.

BIO-DIAGNOSTICS LTD.

United Kingdom of Great Britain and Northern Ireland · Worcestershire Worcestershire
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Australia, Israel — 3 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
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 2 1
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 States1 registration records, 0 510(k), 0 PMA, 288 excluded
Brazil0 confirmed, 123 excluded
Saudi Arabia0 confirmed, 23 excluded
Canada0 confirmed, 42 excluded
Manufacturer names merged into this page: BIO-DIAGNOSTICS LTD.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Worcestershire Worcestershire

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
BIO - DIAGNOSTICS LIMITED
Company number
01464021
Registration status
Active
Legal form
Private Limited Company
Incorporated
1979-11-30
Principal activity
72110 - Research and experimental development on biotechnology
Registered address
UPTON INDUSTRIAL ESTATE RECTORY ROAD, WORCESTER, WR8 0LX

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

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific 1

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