HomeAustriaTECHNOCLONE HERSTELLUNG VON DIAGNOSTIKA UND ARZNEIMITTEL GMBH

TECHNOCLONE HERSTELLUNG VON DIAGNOSTIKA UND ARZNEIMITTEL GMBH

Austria
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Russia — 3 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
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
14registered devices
Class I 1Class II 13
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
3active registrations
Class 1 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 States0 registration records, 1 510(k), 0 PMA, 1 excluded
Brazil14 confirmed, 1 excluded
Manufacturer names merged into this page: TECHNOCLONE HERSTELLUNG VON DIAGNOSTIKA UND ARZNEIMITTEL GMBH

Company information

Country
Austria

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 510(k) clearances by year

12024 · DEN230024

Registration details (sample)

MarketIdentifierNameClass / date
USDEN230024Technozym ADAMTS13 Activity2024-02-28
BR81816720028TECHNOFLUOR ADAMTS13 ActivityClass II
BR81816720029TECHNOFLUOR FXIII ActivityClass II
BR81816720030FAMILIA DE CONTROLES DE COAGULAÇÃO NORMAL,ANORMAL E REFERENCIAClass II

Similar companies

Advantage Austria Wirtschaftskammer OE Messebe
Austria · markets 0
AMACO GmbH
Austria · markets 0
CNSystems Medizintechnik GmbH
Austria · markets 7
ELMET Elastomere Produktions- und Dienstleistu
Austria · markets 0
Feller GmbH
Austria · markets 0
H+H SYSTEM GmbH
Austria · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →