HomeChinaShenzhen Hexin Zondan Medical Equipment Co., Ltd.

Shenzhen Hexin Zondan Medical Equipment Co., Ltd.

China · Shenzhen Guangdong
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Australia, Hong Kong, 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 3 registration records and 1 510(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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
2valid listings
Class III 2
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 States3 registration records, 1 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd · SHENZHEN HEXIN ZONDAN MEDICAL EQUIPMENT CO. LTD

Company information

Country
China
City
Shenzhen Guangdong

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

12021 · K203854

FDA listed device types

Oximeter, Wellness 1Oximeter, Infrared, Sporting, Aviation 1Oximeter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK203854Pulse Oximeter2021-04-23
BR10424960004OXÍMETRO DE DEDO NCSClass II

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