HomeSwitzerlandThoratec Switzerland GMBH

Thoratec Switzerland GMBH

Switzerland · Zurich
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Russia — 7 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 1Class II 3Class III 1unclassified 1
plus 8 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
5active ARTG entries
Class I 1IIa 2IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2b 1Class 3 1
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 States8 registration records, 0 510(k), 0 PMA, 8 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Thoratec Switzerland GMBH · THORATEC SWITZERLAND GMBH

Company information

Country
Switzerland
City
Zurich

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

Blood Pump For Ecmo, Long-Term (> 6 Hours) Use 1Control, Pump Speed, Cardiopulmonary Bypass 1Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 1Ventricular (Assist) Bypass 1Accessory Equipment, Cardiopulmonary Bypass 1Right Ventricular Bypass (Assist) Device 1

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