HomeGermanyDiaSorin Deutschland GmbH

DiaSorin Deutschland GmbH

Germany · Dietzenbach Hesse
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, Israel — 4 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
16listed device types
Class I 9Class II 6Class III 0unclassified 1
plus 14 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 1 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States14 registration records, 0 510(k), 0 PMA, 11 excluded
Brazil1 confirmed, 10 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: DiaSorin Deutschland GmbH · DIASORIN DEUTSCHLAND GMBH

Company information

Country
Germany
City
Dietzenbach Hesse

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

showing 8 of 16
Radioimmunoassay, Follicle-Stimulating Hormone 1Radioimmunoassay, Prolactin (Lactogen) 1Radioimmunoassay, Immunoreactive Insulin 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Analyzer, Chemistry, Micro, For Clinical Use 1Radioimmunoassay, Human Growth Hormone 1Radioimmunoassay, C-Peptides Of Proinsulin 1Radioimmunoassay, Luteinizing Hormone 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10339840145ANALISADOR DE QUIMIOLUMINESCENCIA LIAISONClass II

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