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Medical Device Big Data and Compliance Strategy Research Center

China · 北京 · mdcc.org.cn

✓ Record-verifiedregistrations found in 1 marketsUnified social credit code 91110105MA01KWBB45

This company has registrations in United States — 1 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(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.

European Union1,432 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States0 registration records, 1 510(k), 0 PMA, 1 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

Regulatory identity

Unified social credit code: 91110105MA01KWBB45
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

Medical Device Big Data and Compliance Strategy Research Center

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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