HomeSwitzerlandSTRAUB MEDICAL AG

STRAUB MEDICAL AG

Switzerland · Wangs Sankt Gallen
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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
3listed device types
Class I 0Class II 3Class III 0
plus 5 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
10 including historic records
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
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
2valid listings
Class IV 2
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
2active registrations
Class 2b 2
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 States5 registration records, 1 510(k), 0 PMA, 1 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: STRAUB MEDICAL AG

Company information

Country
Switzerland
City
Wangs Sankt Gallen

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

12018 · K172315

FDA listed device types

Catheter, Peripheral, Atherectomy 1Peripheral Mechanical Thrombectomy With Aspiration 1Wire, Guide, Catheter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK172315Straub Endovascular System2018-04-12
BR80689099025Drive SystemClass II
BR80202910020SISTEMA STRAUB ROTAREXClass II
BR80202910083Sistema de Orientação StraubClass II

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