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Sorin CRM SAS

France · Clamart Hauts-De-Seine

✓ 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

11listed device types

Class I 1Class II 2Class III 8

plus 7 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

3active device licences

Class IV 3

5 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 States7 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 2 excluded

Canada3 confirmed, 1 excluded

Manufacturer names merged into this page: Sorin CRM SAS · SORIN CRM S.A.S.

FDA listed device types

showing 8 of 11

Defibrillator, Implantable, Dual-Chamber 1Pacemaker/Icd/Crt Non-Implanted Components 1Implantable Pacemaker Pulse-Generator 1Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) 1Pulse Generator, Permanent, Implantable 1Implantable Pulse Generator, Pacemaker (Non-Crt) 1Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes 1Implantable Cardioverter Defibrillator (Non-Crt) 1

Market	Identifier	Name	Class / date
CA	35708	ALTO DR ICD	Class IV
CA	63668	ELA RHAPSODY RATE-RESPONSIVE PACEMAKERS	Class IV
CA	64225	ALTO 2 VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	Class IV

Sorin CRM SAS

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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