HomeChinaSHANGHAI MEDCONN BIOTECHNOLOGY CO., LTD.

SHANGHAI MEDCONN BIOTECHNOLOGY CO., LTD.

China · Jinshan District Shanghai
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Singapore, South Korea, Australia, Russia — 6 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 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class II 6
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
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
2active ARTG entries
IVD Class 2 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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, 0 510(k), 0 PMA, 2 excluded
Brazil6 confirmed, 2 excluded
Manufacturer names merged into this page: SHANGHAI MEDCONN BIOTECHNOLOGY CO., LTD.

Company information

Country
China
City
Jinshan District 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 listed device types

Hemoglobin A1c Test System 1Assay, Glycosylated Hemoglobin 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10377390334KL HC-8000Class II
BR10009010451HbA1c Reagent Kit Hb-20Class II
BR10009010452HbA1c Reagent Kit Hb-100Class II

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