11 results
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71ms
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Sources: EU EUDAMED, US FDA
Wellysis Corp.
Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·MTIC InterCert S.r.l.
S-Patch Ex
FDA registration
WELLYSIS CORP.·1 product·🇰🇷 South Korea
S-Patch ExL
FDA registration
WELLYSIS CORP.·1 product·🇰🇷 South Korea
GENERAL PURPOSE ELECTROCARDIOGRAPHS
Device
EU MDD
·
Eu Md Class 2a
·Wellysis Corp.·On the market·5 countries
S-Patch Ex
FDA UDI
Wellysis Corp.·08800159500015·
S-Patch ExL
FDA UDI
Wellysis Corp.·08800159500022·
S-Patch (S-Patch ExL)
FDA 510(k)
FDA Class 2
·Cardiovascular
S-Patch Ex Wearable ECG Patch
FDA 510(k)
FDA Class 2
·Cardiovascular
S-Patch Ex
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Wellysis Corp.·1 device
0068/QCO-DM/165-2020
Certificate
MDD Annex II (excluding section 4)·Wellysis Corp.·MTIC InterCert S.r.l.·1 Basic UDI-DI
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices