HomeHong KongHarvard Medical Devices , Ltd.

Harvard Medical Devices , Ltd.

Hong Kong · Tsimshatsui
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
5510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 5 510(k)
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
4active device licences
Class II 4
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States0 registration records, 5 510(k), 0 PMA, 4 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada4 confirmed, 2 excluded
Manufacturer names merged into this page: HARVARD MEDICAL DEVICES LTD.

Company information

Country
Hong Kong
City
Tsimshatsui

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

22008 · K081159
12009 · K092557
22010 · K100620

Registration details (sample)

MarketIdentifierNameClass / date
USK100620FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-5502010-07-02
USK092558WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES2010-03-17
USK092557DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES2009-12-17
CA80123TENS MACHINE, DIGITAL PAIN RELIEVERClass II
CA80124DIGITAL EAR THERMOMETERClass II
CA80125BLOOD PRESSURE MONITORSClass II

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