HomeSwitzerlandSTRATEC Switzerland AG

STRATEC Switzerland AG

Switzerland · Beringen Schaffhausen
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, South Korea — 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
6listed device types
Class I 3Class II 3Class III 0
plus 9 registration records and 0 510(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
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
5GMP quality-system certificates
IVD import 5
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 States9 registration records, 0 510(k), 0 PMA, 3 excluded
Brazil0 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: STRATEC Switzerland AG

Company information

Country
Switzerland
City
Beringen Schaffhausen

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

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis 1Analyzer, Chemistry, Micro, For Clinical Use 1Real Time Nucleic Acid Amplification System 1Flow Cytometric Reagents And Accessories. 1Instrumentation For Clinical Multiplex Test Systems 1

Similar companies

7S Medical International AG
Switzerland · markets 1
AD Swiss MedTech SA
Switzerland · markets 0
Agappe Diagnostics Switzerland GmbH
Switzerland · markets 2
Alivion AG
Switzerland · markets 0
Amcor plc
Switzerland · markets 1
Angst+Pfister Sensors and Power AG
Switzerland · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →