HomeChinaSHANGHAI MEDCONN MEDICAL TECHNOLOGY CO., LTD.

SHANGHAI MEDCONN MEDICAL TECHNOLOGY CO., LTD.

China · Shanghai
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 3 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
2listed device types
Class I 0Class II 2Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
IVD Class 1 1
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 States2 registration records, 2 510(k), 0 PMA, 1 excluded
Brazil2 confirmed, 2 excluded
Manufacturer names merged into this page: SHANGHAI MEDCONN MEDICAL TECHNOLOGY CO., LTD. · SHANGHAI MEDCONN MEDICAL TECHNOLOGY CO., LTD

Company information

Country
China
City
Shanghai

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

12025 · K242911
12026 · K252749

FDA listed device types

Hemoglobin A1c Test System 1Assay, Glycosylated Hemoglobin 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252749Medconn 8K Glycated Hemoglobin Test System2026-01-06
USK242911Medconn Glycated Hemoglobin Test system2025-06-20
BR10377390334KL HC-8000Class II
BR10009010435Família VERCENTRA HBClass II

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