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TECAN AUSTRIA GMBH

Austria · Groedig Salzburg

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Australia, Israel, Russia — 5 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

6listed device types

Class I 5Class II 0Class III 0unclassified 1

plus 6 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 3Class 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

3active ARTG entries

IVD Class 1 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 States6 registration records, 0 510(k), 0 PMA, 7 excluded

Brazil4 confirmed, 2 excluded

Manufacturer names merged into this page: TECAN AUSTRIA GMBH · TECAN ÁUSTRIA GMBH

FDA listed device types

Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Calculator/Data Processing Module, For Clinical Use 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Fluorometer, For Clinical Use 1Slide Stainer, Automated 1Test, Equipment, Automated Bloodborne Pathogen 1

Market	Identifier	Name	Class / date
BR	10339840410	INFINITE F50	Class II
BR	80144950471	COLUMBUS (PLUS)	Class I
BR	10339849002	HYDROFLEX DIASORIN	Class I

TECAN AUSTRIA GMBH

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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