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Quantimetrix Corporation

USA · Redondo Beach CA · quantimetrix.com

✓ Record-verifiedregistrations found in 8 markets

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

0UDI-DI device records

USUnited StatesFDA openFDA

7listed device types

Class I 5Class II 2Class III 0

plus 19 registration records and 39 510(k)

UKUnited KingdomMHRA PARD

6registered device records

IVD general 6

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

6active device licences

Class II 5Class III 1

26 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

7device registrations

CLASS B 7

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

9active ARTG entries

IVD Class 1 2IVD Class 2 7

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 States19 registration records, 39 510(k), 0 PMA, 1 excluded

United Kingdom6 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: QUANTIMETRIX CORP.

Regulatory identity

UK responsible person: MDSS-UK RP LIMITED

FDA 510(k) clearances by year

51983

31984

41985

31986

11988

11991

31993

21994

11995

21997

11999

22001

22002

22003

32006

12011

12012

12015

12016

FDA listed device types

Urinalysis Controls (Assayed And Unassayed) 1Multi-Analyte Controls, All Kinds (Assayed) 1Electrophoretic Separation, Lipoproteins 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Electrolyte Controls (Assayed And Unassayed) 1Biuret (Colorimetric), Total Protein 1Mixture, Hematology Quality Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	59364	Sweat Control for Cystic Fibrosis Testing, Level1, Level 2, Level 3	IVD general
UK	55866	Spinalscopics Spinal Fluid Cell Count Control Level 2	IVD general
UK	30219	Dipper POCT® Urinalysis Dipstick Control, Level 1 & 2	IVD general
US	K152117	Dropper hsCRP High Sensitivity CRP Control	2016-04-21
US	K142262	AUTION CHECK PLUS	2015-04-10
US	K113177	COMPLETE D 25-OH VITAMIN D CONTROL	2012-05-10
CA	31684	HDL PLUS CONTROL	Class II
CA	31693	QUANTTEST RED TOTAL PROTEIN ASSAY SYSTEM	Class II
CA	31696	DRUGS OF ABUSE URINE SCREEN CTRL.	Class II