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DRG INSTRUMENTS GMBH

Germany · Marburg

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Israel, Russia — 7 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

97listed device types

Class I 54Class II 43Class III 0

plus 138 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

36registered devices

Class I 1Class II 35

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

1active device licences

Class II 1

3 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

18device registrations

CLASS B 18

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

17active registrations

Class 1 6Class 2a 5Class 2b 6

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 States138 registration records, 0 510(k), 0 PMA, 2 excluded

Brazil36 confirmed, 1 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: DRG INSTRUMENTS GMBH

FDA listed device types

showing 8 of 97

Antigen, Fluorescent Antibody Test, Schistosoma Mansoni 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Antisera, Cf, Influenza Virus A, B, C 1Reagent, Immunoassay, Igg 1Radioimmunoassay, Prolactin (Lactogen) 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Sperm, Antigen, Antiserum, Control 1Wright'S Stain 1

Market	Identifier	Name	Class / date
BR	80915630018	DRG: HYBRiD XL	Class II
BR	80680420080	DRG CORTISOL SALIVAR ELISA	Class II
BR	80680420081	DRG CORTISOL ELISA	Class II
CA	90282	ALPHA AMYLASE SALIVA ENZ-5127	Class II

DRG INSTRUMENTS GMBH

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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