Home›USA›Euroimmun Us, Inc.

Euroimmun Us, Inc.

USA · Mountain Lakes

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

76listed device types

Class I 37Class II 38Class III 0unclassified 1

plus 105 registration records and 37 510(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

0active device licences

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 States105 registration records, 37 510(k), 0 PMA, 2 excluded

Brazil0 confirmed, 3 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: EUROIMMUN US INC.

FDA 510(k) clearances by year

32006

32007

62009

32010

22012

52013

42014

22015

32016

12017

32018

12019

12020

FDA listed device types

showing 8 of 76

Antigen, Fluorescent Antibody Test, Schistosoma Mansoni 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Antisera, Cf, Parainfluenza Virus 1-4 1Microscope, Fluorescence/U.V. 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Radioimmunoassay, Prolactin (Lactogen) 1Respiratory Syncytial Virus - Elisa 1Radioimmunoassay, Estriol 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193115	EUROIMMUN Anti-BP230-CF ELISA (IgG)	2020-09-17
US	K183313	EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)	2019-02-28
US	K172582	EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern	2018-05-24

Euroimmun Us, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies