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Advanced Circulatory Systems, Inc.

USA · Roseville

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Israel — 5 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

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

1active device licences

Class II 1

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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, 3 510(k), 0 PMA, 2 excluded

Brazil1 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ADVANCED CIRCULATORY SYSTEMS, INC. · ACSI - ADVANCED CIRCULATORY SYSTEMS INC. (ZOLL INTRATHORACIC PRESSURE REGULATION (IPR) DIV

Registration details (sample)

Market	Identifier	Name	Class / date
US	K070490	CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)	2007-06-20
US	K040084	LIFESTYLE CIRCULATORY ENHANCER	2004-04-07
US	K033401	MODIFICATION TO RESQPOD CIRCULATORY ENHANCER	2003-11-20
BR	10429990060	Dispositivo de Limiar de Impedância ResQGARD	Class II
CA	20770	RESUSCI-VALVE ITV	Class II

Advanced Circulatory Systems, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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