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Sigma Diagnostics, Inc.

USA · St. Louis

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

164510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 164 510(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

78active device licences

Class II 76Class III 2

79 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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, 164 510(k), 0 PMA, 27 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada78 confirmed, 3 excluded

Manufacturer names merged into this page: SIGMA DIAGNOSTICS · FIRST MEDICAL, INC. (A SIGMA DIAGNOSTICS COMPANY)

Registration details (sample)

Market	Identifier	Name	Class / date
US	K021162	AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED	2002-08-30
US	K020109	SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL	2002-02-06
US	K013549	SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971	2001-12-26
CA	14826	INFINITY CO2 REAGENTS	Class II
CA	14827	D-B-HYDROXYBUTYRATE (B-HBA) REAGENT KIT	Class II
CA	14832	SALICYLATE	Class II

Sigma Diagnostics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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