HomeDominican RepublicCCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG

CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG

Dominican Republic · Haina San Cristobal
✓ 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
23listed device types
Class I 2Class II 21Class III 0
plus 38 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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
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 States38 registration records, 0 510(k), 0 PMA
Manufacturer names merged into this page: CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG

Company information

Country
Dominican Republic
City
Haina San Cristobal

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

showing 8 of 23
Stand, Infusion 1Clamp, Surgical, General & Plastic Surgery 1Probe, Thermodilution 1Medium-Term Adjunctive Predictive Cardiovascular Indicator 1Catheter, Intravascular, Diagnostic 1Transducer, Pressure, Catheter Tip 1Clamp, Vascular 1Catheter, Continuous Flush 1

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