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Home›USA›Sorin Biomedica Cardio S.R.L.

Sorin Biomedica Cardio S.R.L.

USA · Austin
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Israel — 4 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
21510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 21 510(k), 3 PMA
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
10active device licences
Class II 10
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
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 States0 registration records, 21 510(k), 3 PMA, 7 excluded
Brazil0 confirmed, 3 excluded
Canada10 confirmed, 3 excluded
Manufacturer names merged into this page: SORIN BIOMEDICA INC.
Same-named companies — This database also contains companies with near-identical names: SORIN BIOMEDICA INC., Sorin Biomedical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Austin

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

41980
21983
41984
11985
21986
11992
51993
11994
12007

Registration details (sample)

MarketIdentifierNameClass / date
USK071327MEMO 3D SEMIRIGID ANNULOPLASTY RING2007-08-10
USK931444PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS1994-05-27
USK925661STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE1993-05-18
CA7128SORIN EMBOLECTOMY CATHETERClass II
CA7130CARDIAC INSULATION PADClass II
CA7131VEIN IRRIGATION CANNULAClass II

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