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ZOLL MEDICAL CORPORATION

USA · Chelmsford

✓ 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

32listed device types

Class I 8Class II 20Class III 4

plus 58 registration records and 84 510(k), 119 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 3Class III 1Class IV 2

90 including historic records

TWTaiwanTFDA

14valid device licences

Class II 7Class III 7

SGSingaporeHSA SMDR

11device registrations

CLASS B 1CLASS C 6CLASS D 4

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

36active ARTG entries

Class I 15Class III 6IIa 3IIb 10Class Is (sterile) 2

HKHong KongMDACS

4valid listings

Class III 3Class IV 1

ILIsraelAMAR

21registrations

RURussiaRoszdravnadzor

9active registrations

Class 1 1Class 2b 8

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 States58 registration records, 84 510(k), 119 PMA, 8 excluded

Brazil1 confirmed, 3 excluded

Canada6 confirmed, 2 excluded

Manufacturer names merged into this page: ZOLL MEDICAL CORPORATION · ZOLL Medical Corporation · SUZHOU ZOLL MEDICAL TECHNOLOGY CO., LTD.

FDA 510(k) clearances by year

22000

22001

22002

32003

32004

42005

22006

42007

52008

52009

42010

92011

82012

12013

62014

12015

22017

22018

12021

12024

FDA listed device types

showing 8 of 32

Strap, Head, Gas Mask 1Kit, First Aid, Talking 1Stand, Infusion 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1Transducer, Gas Flow 1Battery, Replacement, Rechargeable 1Support, Breathing Tube 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233486	731 Series Ventilator	2024-12-13
US	K202375	ZOLL Propaq M	2021-03-09
US	K180482	ZOLL Propaq M	2018-11-30
BR	10429990060	Dispositivo de Limiar de Impedância ResQGARD	Class II
CA	7088	IMPACT 304 ELECTRONIC SUCTION SYSTEM (ASPIRATOR)	Class II
CA	13076	IMPACT UNI-VENT PORTABLE VENTILATOR	Class III
CA	78090	RECHARGEABLE SEALED LEAD ACID (SLA) DEFIBRILLATOR BATTERIES	Class II