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Andon Medical Co., Ltd.

China · Tianjin
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 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
17listed device types
Class I 1Class II 14Class III 0unclassified 2
plus 33 registration records and 10 510(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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
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 States33 registration records, 10 510(k), 0 PMA, 2 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Andon Medical co., LTD
Same-named companies — This database also contains companies with near-identical names: Andon Medical Systems, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Tianjin

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

11983
22010 · K102609
42011 · K112738
22012 · K120813
12013 · K123935

FDA listed device types

showing 8 of 17
Analyzer, Body Composition, Exempt 1Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Kit, Test, Pregnancy, Hcg, Over The Counter 1System, Measurement, Blood-Pressure, Non-Invasive 1Multi-Analyte Respiratory Virus Antigen Detection Test 1Glucose Dehydrogenase, Glucose 1Over-The-Counter Covid-19 Antigen Test 1Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch 1

Registration details (sample)

MarketIdentifierNameClass / date
USK123935IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM2013-04-12
USK120813BLOOD GLUCOSE MONITORING SYSTEM2012-12-07
USK110017AG-608N BLOOD GLUCOSE MONITORING SYSTEM2012-01-18

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