HomeChinaShenzhen Upnmed Equipment Co., LTD

Shenzhen Upnmed Equipment Co., LTD

China · Shenzhen Guangdong · www.upnmed.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000019212

This company has registrations in European Union, United States, Brazil, Saudi Arabia, Taiwan, 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
7UDI-DI device records
Class I 2Class IIb 5
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
14registered devices
Class I 6Class II 8
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
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 Union7 raw hits, 0 excluded, 7 confirmed
United States1 registration records, 1 510(k), 0 PMA
Brazil14 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN UPNMED EQUIPMENT CO., LTD. · SHENZHEN UPNMED EQUIPMENT CO LTD. · Shenzhen Upnmed Equipment Co.,Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000019212
EU authorised representative
R Sight B.V.

Company information

Country
China
City
Shenzhen Guangdong
Website
www.upnmed.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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

12019 · K183277

FDA listed device types

Oximeter 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06970404880031UpnMedClass IIb
EU06970404880000UpnMedClass IIb
EU06970404880017UpnMedClass IIb
EU06970404880024UpnMedClass IIb
USK183277SpO2 Sensor2019-05-15
BR81178359007Sonda de Temperatura U6xx SeriesClass II
BR82597659003Sensor de SpO2Class II
BR82796460010Braçadeira PNI descartável SDM NeonatalClass I
SAME0000006184SFDAA00002NIBP CUFF
SAME0000006184SFDAA00003ECG Cable with Leadwires

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