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Cardioline S.P.A.

Italy · Trento Trento

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Singapore, Australia, Israel, Russia — 6 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

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

8device registrations

CLASS B 8

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 2IIa 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 3

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 States2 registration records, 4 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: Cardioline S.P.A. · CARDIOLINE SPA

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220526	HD+12, HD+15	2023-05-15
US	K160746	CARDIOLINE touchECG	2016-11-02
US	K160840	ECG100+, ECG200+	2016-08-12
BR	83004990002	CUBESTRESS	Class II
BR	80303619001	Eletrocardiógrafo	Class II

Cardioline S.P.A.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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