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EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG

Germany · Lubeck

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

59listed device types

Class I 29Class II 29Class III 0unclassified 1

plus 130 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

80registered devices

Class I 9Class II 71

162 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

102active device licences

Class II 83Class III 19

349 including historic records

TWTaiwanTFDA

105valid device licences

Class I 35Class II 70

SGSingaporeHSA SMDR

135device registrations

CLASS B 109CLASS C 26

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

37active ARTG entries

IVD Class 1 3IVD Class 2 8IVD Class 3 26

HKHong KongMDACS

9valid listings

IVD B 5IVD C 4

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 1Class 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 States130 registration records, 0 510(k), 0 PMA

Brazil80 confirmed, 0 excluded

Canada102 confirmed, 0 excluded

Manufacturer names merged into this page: EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG · EUROIMMUN Medizinische Labordiagnostika AG

FDA listed device types

showing 8 of 59

Anti-Rnp Antibody, Antigen And Control 1Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) 1Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) 1Anti-Dna Indirect Immunofluorescent Solid Phase 1Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use 1Reagent, Borrelia Serological Reagent 1Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) 1Extractable Antinuclear Antibody, Antigen And Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	81148560049	Myfoodprofile	Class II
BR	10338930285	IIFT Bartonella henselae/Bartonella quintana (IgM)	Class II
BR	10338930283	IIFT - Bartonella henselae/Bartonella quintana (IgG)	Class II
CA	66559	ANTI-RUBELLA VIRUS ELISA (IGG)	Class III
CA	68458	EUROLINE ANTI-MPO,-PR3 (IGG)	Class II
CA	68577	ANTI-HELICOBACTER PYLORI EUROLINE-WESTERNBLOT (IGG)	Class II

EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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