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ATCOR MEDICAL INC

✓ Record-verifiedregistrations found in 7 marketsEU SRN AU-MF-000034116

This company has registrations in European Union, United States, United Kingdom, Canada, Singapore, Australia, Israel — 7 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

3UDI-DI device records

Class IIa 3

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 6 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

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

0active device licences

4 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 3IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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.

European Union3 raw hits, 0 excluded, 3 confirmed

United States6 registration records, 5 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Manufacturer names merged into this page: ATCOR MEDICAL Pty Ltd · ATCOR MEDICAL PTY LTD

Regulatory identity

EU manufacturer SRN: AU-MF-000034116
EU authorised representative: Advena Limited
UK responsible person: Advena Ltd
Exhibition record: CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

12002 · K012487

12007 · K070795

12008 · K080670

12012 · K122129

12023 · K221742

FDA listed device types

Computer, Blood-Pressure 1Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) 1System, Measurement, Blood-Pressure, Non-Invasive 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	19351315000048	Non–Invasive Blood Pressure Monitoring Instruments	Class IIa
EU	19351315000093	Tonometer	Class IIa
EU	19351315000031	Non–Invasive Blood Pressure Monitoring Instruments	Class IIa
UK	36553	SphygmoCor XCEL	Class IIa
US	K221742	CONNEQT PULSE	2023-04-21
US	K122129	SPHYGMOCOR XCEL	2012-11-16
US	K080670	MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM	2008-04-23

ATCOR MEDICAL INC

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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