Home›USA›RANDOX LABORATORIES-US, LTD

RANDOX LABORATORIES-US, LTD

USA · Kearneysville

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, 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

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

159registered devices

Class I 14Class II 145

163 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

8valid device licences

Class I 4Class II 4

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

22active ARTG entries

IVD Class 1 3IVD Class 2 13IVD Class 3 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

8active registrations

Class 1 4Class 2a 4

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

Brazil159 confirmed, 4 excluded

Canada184 confirmed, 0 excluded

Manufacturer names merged into this page: RANDOX LABORATORIES LIMITED · RANDOX LABORATORIES-US, LTD · RANDOX LABORATORIES LTD. · RANDOX LABORATORIES LTD

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)

Market	Identifier	Name	Class / date
US	K250741	Evidence MultiSTAT DOA Urine MultiPlex	2026-01-23
US	DEN240035	ConcizuTrace ELISA	2025-05-22
US	K220451	Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT	2023-10-05
BR	80158990085	CALIBRADOR DE PROTEINAS ESPECIFICAS	Class II
BR	80158990218	CONTROLE DE RANSOD	Class II
BR	80158990008	FOSFATASE ALCALINA	Class II
CA	64979	CRP CALIBRATOR	Class II
CA	64980	LIQUID CRP CONTROL LEVEL II & III	Class II
CA	64981	HIGH SENSITIVITY CRP CONTROL LEVEL I & II	Class II

RANDOX LABORATORIES-US, LTD

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies