HomeUnited Kingdom of Great Britain and Northern IrelandFortress Diagnostics Limited

Fortress Diagnostics Limited

United Kingdom of Great Britain and Northern Ireland · Antrim Northern Ireland · www.fortressdiagnostics.com
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United Kingdom, Brazil, 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
0UDI-DI device records
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
396registered device records
IVD general 396
BRBrazilANVISA
3registered devices
Class II 3
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
0valid device licences
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, 0 510(k), 0 PMA, 4 excluded
United Kingdom396 confirmed, 0 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: FORTRESS DIAGNOSTICS LIMITED

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Antrim Northern Ireland
Website
www.fortressdiagnostics.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

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
FORTRESS DIAGNOSTICS LTD
Company number
NI038167
Registration status
Active
Legal form
Private Limited Company
Incorporated
2000-03-21
Principal activity
20590 - Manufacture of other chemical products n.e.c. / 32990 - Other manufacturing n.e.c.
Registered address
9A THE TECHNOLOGY PARK, ANTRIM, BT41 1QS

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

Registration details (sample)

MarketIdentifierNameClass / date
UK38243D3-Hydroxybutyrate CalibratorIVD general
UK6357717a-OH ProgesteroneIVD general
UK42656EDDPIVD general
BR80464810807CITRATE (Urinary)Class II
BR80464810816OXALATE (Urinary)Class II
BR80464810802Anti H pylori IgMClass II

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