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EKF-DIAGNOSTICS GMBH

Germany

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 9 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

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

29active device licences

Class II 29

60 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 States9 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil5 confirmed, 1 excluded

Canada29 confirmed, 0 excluded

Manufacturer names merged into this page: EKF DIAGNOSTIC GMBH · EKF DIAGNOSTICS,INC, ATA STANDBIO LABORATORY, LLC, SEPARATION TECH, INC, AND EKF LIFE SCI. · EKF-DIAGNOSTIC GMBH · EKF-DIAGNOSTIC · EKF-DIAGNOSTICS GMBH

FDA 510(k) clearances by year

12003 · K031898

12011 · K110393

12018 · K172173

12019 · K180509

12020 · K200909

FDA listed device types

Calculator/Data Processing Module, For Clinical Use 1Whole Blood Hemoglobin Determination 1System, Hemoglobin, Automated 1Control, Hemoglobin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200909	Hemo Control (optional Add Pack Hemo Control DM)	2020-06-12
US	K180509	Quo-Test A1c System	2019-02-16
US	K172173	DiaSpect Tm, DiaSpect Tm Cuvettes	2018-04-06
BR	80131480008	FAMÍLIA KIT SOLUÇÃO CONTROLE HB - VJR	Class II
BR	80131480006	SISTEMA PARA MEDIÇÃO DE HEMOGLOBINA	Class II
BR	10234400224	Solução Controle Hb-con para Sistema de Medição de Hemoglobina	Class II
CA	67562	RAPET ASO	Class II
CA	67563	RAPET CRP	Class II
CA	67570	CHOLESTEROL LIQUICOLOR	Class II

EKF-DIAGNOSTICS GMBH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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