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SORIN BIOMEDICA INC.

USA · Irvine

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

36510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 36 510(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

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 States0 registration records, 36 510(k), 3 PMA, 6 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 Cardio S.R.L., Sorin Biomedical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K071327	MEMO 3D SEMIRIGID ANNULOPLASTY RING	2007-08-10
US	K990103	MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE	1999-11-05
US	K963759	DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS	1998-02-20
CA	7128	SORIN EMBOLECTOMY CATHETER	Class II
CA	7130	CARDIAC INSULATION PAD	Class II
CA	7131	VEIN IRRIGATION CANNULA	Class II

SORIN BIOMEDICA INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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