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Home›China›SEAMATY DIAGNOSTIC CO., LTD.

SEAMATY DIAGNOSTIC CO., LTD.

China · Guangming Shenzhen · www.seamaty.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000033945

This company has registrations in European Union, Brazil, Israel — 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
24UDI-DI device records
IVD A 24
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
5registered devices
Class II 5
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
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 Union24 raw hits, 0 excluded, 24 confirmed
Brazil5 confirmed, 1 excluded
Manufacturer names merged into this page: SEAMATY DIAGNOSTIC CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000033945
EU authorised representative
MedNet EC-REP GmbH

Company information

Country
China
City
Guangming Shenzhen
Website
www.seamaty.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

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.

Registration details (sample)

MarketIdentifierNameClass / date
EU06975347780530Automatic Hematology AnalyzerIVD A
EU06975347780547Automatic Hematology AnalyzerIVD A
EU06975347780004Automatic Hematology AnalyzerIVD A
EU06975347780011Auto Chemistry AnalyzerIVD A
BR81797610057Analisador de Gasometria SMT-SG1Class II
BR81797610058Cartucho teste gasometria SG1-BG10Class II
BR80474870130Analisador de Gases e Eletrólitos Sanguíneos - GT Hand GasmeterClass II

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