DiaMed GmbH

Switzerland · Cressier Fr

✓ 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

7listed device types

Class I 1Class II 6Class III 0

plus 21 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 9Class II 5

31 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

15 including historic records

TWTaiwanTFDA

74valid device licences

Class I 3Class II 67Class III 4

SGSingaporeHSA SMDR

40device registrations

CLASS C 12CLASS D 28

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

11active ARTG entries

IVD Class 1 3IVD Class 3 4IVD Class 4 4

HKHong KongMDACS

18valid listings

IVD B 1IVD C 7IVD D 10

ILIsraelAMAR

15registrations

RURussiaRoszdravnadzor

37active registrations

Class 1 4Class 2a 7Class 2b 2Class 3 24

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 States21 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil14 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: DiaMed GmbH · DIAMED GMBH

FDA listed device types

Blood Establishment Computer Software And Accessories 1Media, Potentiating For In Vitro Diagnostic Use 1System, Test, Automated Blood Grouping And Antibody 1Manual Blood Grouping And Antibody Test Systems 1Solution, Stabilized Enzyme 1Kit, Quality Control For Blood Banking Reagents 1Diluent, Blood Cell 1

Market	Identifier	Name	Class / date
BR	80020690479	Família de Leitoras de Reações de Aglutinação	Class II
BR	80020690480	IH-Com	Class I
BR	80020690481	Família de ID-Incubadoras	Class I

DiaMed GmbH

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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