HomeUnited Kingdom of Great Britain and Northern IrelandRANDOX LABORATORIES LIMITED

RANDOX LABORATORIES LIMITED

United Kingdom of Great Britain and Northern Ireland · Crumlin
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Hong Kong, Israel — 8 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
125listed device types
Class I 44Class II 80Class III 0unclassified 1
plus 231 registration records and 134 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
167registered devices
Class I 14Class II 153
171 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
184active device licences
Class II 182Class III 2
231 including historic records
TWTaiwanTFDA
19valid device licences
Class I 16Class II 2Class III 1
SGSingaporeHSA SMDR
16device registrations
CLASS B 16
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
9valid listings
IVD B 3IVD C 6
ILIsraelAMAR
2registrations
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 States231 registration records, 134 510(k), 0 PMA, 1 excluded
Brazil167 confirmed, 2 excluded
Canada184 confirmed, 0 excluded
Manufacturer names merged into this page: RANDOX LABORATORIES LIMITED · RANDOX LABORATORIES-US, LTD · RANDOX LABORATORIES LTD. · RANDOX LABORATORIES LTD · RANDOX LABORATORIES LIMITED - UK PARA SIEMENS HEALTHCARE DIAGNOSTICS INC - EUA · RANDOX LABORATORIES LTD - UK PARA SIEMENS HEALTHCARE DIAGNOSTICS INC - EUA
Same-named companies — This database also contains companies with near-identical names: RANDOX LABORATORIES-US, LTD. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Crumlin

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

Company number
NI015738
Registration status
Active
Legal form
Private Limited Company
Incorporated
1982-04-20
Principal activity
20590 - Manufacture of other chemical products n.e.c. / 82990 - Other business support service activities n.e.c.
Registered address
ARDMORE, 55 DIAMOND ROAD, CO.ANTRIM, BT29 4QY

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
82000
112001
82002
52003
102004
52005
32006
42010
82011
82012
62013
52014
22015
42016
32017
12018
32023
12025
12026

FDA listed device types

showing 8 of 125
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Acid, Lactic, Enzymatic Method 1Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1Ferrozine (Colorimetric) Iron Binding Capacity 1Titrimetric, Magnesium 1Controls For Blood-Gases, (Assayed And Unassayed) 1Analyzer, Chemistry, Micro, For Clinical Use 1Drug Mixture Control Materials 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250741Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
USDEN240035ConcizuTrace™ ELISA2025-05-22
USK220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT2023-10-05
BR80158990085CALIBRADOR DE PROTEINAS ESPECIFICASClass II
BR80158990218CONTROLE DE RANSODClass II
BR80158990008FOSFATASE ALCALINAClass II
CA64979CRP CALIBRATORClass II
CA64980LIQUID CRP CONTROL LEVEL II & IIIClass II
CA64981HIGH SENSITIVITY CRP CONTROL LEVEL I & IIClass II

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