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ZOLL Circulation, Inc.

USA · San Jose

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

6listed device types

Class I 1Class II 4Class III 1

plus 22 registration records and 13 510(k), 21 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 4Class IV 1

11 including historic records

TWTaiwanTFDA

5valid device licences

Class II 2Class III 3

SGSingaporeHSA SMDR

3device registrations

CLASS C 2CLASS D 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

13active ARTG entries

Class I 5Class III 4IIb 3Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States22 registration records, 13 510(k), 21 PMA

Brazil2 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: ZOLL Circulation, Inc. · ZOLL CIRCULATION, INC. · ZOLL CIRCULATION

FDA 510(k) clearances by year

12006

12008

12010

12012

12014

12015

12016

12021

12022

32023

12025

FDA listed device types

Hyperthermia Monitor 1System, Hypothermia, Intravenous, Cooling 1Compressor, Cardiac, External 1System, Thermal Regulating 1System, Oxygen, Aqueous 1Mattress, Water, Temperature Regulated 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250979	Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)	2025-10-15
US	K231182	Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System	2023-11-03
US	K221700	AutoPulse NXT Resuscitation System	2023-03-09
BR	10429990053	SUK - KIT DE INICIALIZAÇÃO DO CONSOLE THERMOGARD XP	Class II
BR	80117589085	Start-up Kit	Class II
CA	27875	COOLGARD START-UP KIT	Class II
CA	27881	CENTRAL VENOUS HEAT EXCHANGE CATHETER KITS	Class II
CA	66913	COOLGARD 3000	Class IV