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ZOLL Manufacturing Corporation

USA · Pittsburgh

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, 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

5listed device types

Class I 0Class II 4Class III 1

plus 4 registration records and 3 510(k), 195 PMA

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

1active device licences

Class IV 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 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.

United States4 registration records, 3 510(k), 195 PMA, 11 excluded

Brazil0 confirmed, 5 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: ZOLL Manufacturing Corporation · ZOLL MANUFACTURING CORPORATION

FDA 510(k) clearances by year

12018 · K172510

22019 · K190939

FDA listed device types

Electrocardiograph 1Detector And Alarm, Arrhythmia 1Plethysmograph, Impedance 1Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) 1Wearable Automated External Defibrillator 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K190939	ZOLL Arrhythmia Management Sysyem	2019-12-19
US	K182093	ZOLL ECG Analysis Software	2019-01-28
US	K172510	µCor Heart Failure and Arrhythmia Management System	2018-05-11
CA	96006	LIFEVEST MODEL 4000	Class IV

ZOLL Manufacturing Corporation

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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