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EKF DIAGNOSTIC GMBH

Germany · Barleben

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong, 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

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

0active device licences

1 including historic records

TWTaiwanTFDA

6valid device licences

Class I 1Class II 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

HKHong KongMDACS

4valid listings

IVD B 1IVD C 3

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

6active registrations

Class 1 3Class 2a 3

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

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: EKF DIAGNOSTIC GMBH · 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

EKF DIAGNOSTIC 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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