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Home›Italy›SORIN GROUP ITALIA S.R.I.

SORIN GROUP ITALIA S.R.I.

Italy
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
16listed device types
Class I 1Class II 15Class III 0
plus 87 registration records and 61 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
26registered devices
Class I 1Class II 25
44 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
12active device licences
Class II 8Class III 4
36 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
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 States87 registration records, 61 510(k), 0 PMA, 7 excluded
Brazil26 confirmed, 0 excluded
Canada12 confirmed, 3 excluded
Manufacturer names merged into this page: SORIN GROUP ITALIA S.R.L · SORIN GROUP ITALIA S.R.L. · SORIN GROUP ITÁLIA S.R.L. · SORIN GROUP ITALIA S.R.I.
Same-named companies — This database also contains companies with near-identical names: Sorin Group Italia S.R.L.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Italy

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

12003
22006
32007
32008
32009
42010
32011
72012
32013
12014
22015
22017
32018
22019
32020
12021
22023
52024
52025
12026

FDA listed device types

showing 8 of 16
Heat-Exchanger, Cardiopulmonary Bypass 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 1Filter, Blood, Cardiopulmonary Bypass, Arterial Line 1Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 1Cannula, Catheter 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Defoamer, Cardiopulmonary Bypass 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253671Dual Stage Venous Cannulae2026-01-30
USK251783Inspire HCR and HCR DUAL cardiotomy reservoirs2025-12-22
USK253616ProtekDilate Vascular Access Kit2025-12-19
BR80102511463XTRA Aspiration and Anticoagulation Line (AAL)Class II
BR80102511493COLLECTION SET TX CARDIOClass II
BR80102511454INSPIRE com filtro arterial integradoClass II
CA935LILLIPUT NEWBORN OXYGENATORClass III
CA6734DIDECO RECOVERY PUMPClass II
CA6781VENOUS RESERVOIRSClass II

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