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Home›SUZHOU ZOLL MEDICAL TECHNOLOGY CO., LTD.

SUZHOU ZOLL MEDICAL TECHNOLOGY CO., LTD.

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Hong Kong, Israel — 6 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 63 510(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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class III 1
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 States58 registration records, 63 510(k), 119 PMA, 9 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.
Same-named companies — This database also contains companies with near-identical names: ZOLL MEDICAL CORPORATION. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

31999
22000
22001
22002
32003
32004
42005
22006
22007
32008
22009
12010
42011
42012
12013
52014
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)

MarketIdentifierNameClass / date
USK233486731 Series Ventilator2024-12-13
USK202375ZOLL Propaq M2021-03-09
USK180482ZOLL Propaq M2018-11-30
BR10429990060Dispositivo de Limiar de Impedância ResQGARDClass II
CA7088IMPACT 304 ELECTRONIC SUCTION SYSTEM (ASPIRATOR)Class II
CA13076IMPACT UNI-VENT PORTABLE VENTILATORClass III
CA78090RECHARGEABLE SEALED LEAD ACID (SLA) DEFIBRILLATOR BATTERIESClass II

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