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Sorin Group Italia S.R.L.

Italy · Mirandola

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

13valid device licences

Class I 1Class II 9Class III 3

SGSingaporeHSA SMDR

18device registrations

CLASS B 17CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

28active ARTG entries

Class I 1Class III 7IIa 17IIb 2Class Is (sterile) 1

HKHong KongMDACS

14valid listings

Class II 7Class III 1Class IV 6

ILIsraelAMAR

23registrations

RURussiaRoszdravnadzor

14active registrations

Class 2a 7Class 2b 2Class 3 5

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.

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)

Market	Identifier	Name	Class / date
US	K253671	Dual Stage Venous Cannulae	2026-01-30
US	K251783	Inspire HCR and HCR DUAL cardiotomy reservoirs	2025-12-22
US	K253616	ProtekDilate Vascular Access Kit	2025-12-19
BR	80102511463	XTRA Aspiration and Anticoagulation Line (AAL)	Class II
BR	80102511493	COLLECTION SET TX CARDIO	Class II
BR	80102511454	INSPIRE com filtro arterial integrado	Class II
CA	935	LILLIPUT NEWBORN OXYGENATOR	Class III
CA	6734	DIDECO RECOVERY PUMP	Class II
CA	6781	VENOUS RESERVOIRS	Class II