HomeChinaMianyang Meike Electronic Equipment Co., Ltd.

Mianyang Meike Electronic Equipment Co., Ltd.

China · Mianyang Sichuan · www.bladder-scanner.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000002172

This company has registrations in European Union, United States, Canada, Australia, Hong Kong, Israel — 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
2UDI-DI device records
Class IIa 2
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 3 registration records and 3 510(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
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
2registrations
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 Union2 raw hits, 0 excluded, 2 confirmed
United States3 registration records, 3 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: MIANYANG MEIKE ELECTRONIC EQUIPMENT CO.,LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000002172
EU authorised representative
Lotus NL B.V.

Company information

Country
China
City
Mianyang Sichuan
Website
www.bladder-scanner.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsUltrasound (POCUS, AI-guided, portable)

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

12013 · K130229
12019 · K191307
12021 · K210591

FDA listed device types

Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06940912715019Bladder ScannerClass IIa
EU06940912714012Bladder ScannerClass IIa
USK210591Palm Bladder Scanner - PBSV7.12021-06-09
USK191307Palm Bladder Scanner - PBSV5.12019-06-05
USK130229PALM BLADDER SCANNER2013-03-20

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