HomeChinaHANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., LTD.

HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., LTD.

China · Hangzhou
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel, Russia — 7 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
4listed device types
Class I 1Class II 3Class III 0
plus 12 registration records and 10 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
7device registrations
CLASS B 7
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
22active ARTG entries
Class I 1IIa 21
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
RURussiaRoszdravnadzor
6active registrations
Class 1 1Class 2a 5
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 States12 registration records, 10 510(k), 0 PMA, 14 excluded
Brazil3 confirmed, 5 excluded
Saudi Arabia0 confirmed, 4 excluded
Manufacturer names merged into this page: HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., · HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., LTD. · HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD

Company information

Country
China
City
Hangzhou

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

12003
32004
12009
12010
12012
12016
12017
12018

FDA listed device types

Clinical Electronic Thermometer 1Continuous Measurement Thermometer 1System, Measurement, Blood-Pressure, Non-Invasive 1Stethoscope, Manual 1

Registration details (sample)

MarketIdentifierNameClass / date
USK172870Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J2018-02-13
USK172861Digital thermometer(with disposable thermometer cover)2017-12-19
USK160999Infra-red forehead thermometer2016-08-01
BR80560319010TERMÔMETRO DIGITAL MEDLEVENSOHN ML 01Class II
BR81596329005TERMOMETRO CLINICO DIGITAL MULTILASER - HC 070Class II
BR81596320002Termômetro Digital SmartClass II

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