HomeChinaFMI Medical Systems Co.,Ltd

FMI Medical Systems Co.,Ltd

China · 杭州 · www.minfound.com.cn
✓ Record-verifiedregistrations found in 2 marketsUnified social credit code 913306005714650477

This company holds 1 NMPA certificates in China and has registrations in United States — 1 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
1China registrations
Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
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, 2 510(k), 0 PMA, 3 excluded
China1 certificates (Class III 1 / II 0 / I 0), as of 2026-09-04

Regulatory identity

Unified social credit code
913306005714650477
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Employees
500–1000
Annual revenue
over RMB 500M
Company type
Manufacturer
Website
www.minfound.com.cn
Product categories
医用成像器械

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

12018 · K173076
12020 · K192590

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243060369X射线计算机体层摄影设备Class III
USK192590CURA 7782020-03-05
USK173076CURA 16; ScintCare CT162018-10-04

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