15 results
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25ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Finland
×
DELFIA(R) HGH KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Biomarker Analysis Platform
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nightingale Health Oyj·1 device
Thermo Fisher Scientific Oy
Manufacturer
🇫🇮 Finland·TÜV Rheinland LGA Products GmbH
Elekta Oy
Manufacturer
🇫🇮 Finland·1 Basic UDI-DI·1 Device·TÜV Rheinland LGA Products GmbH
VitalSignum Oy
Manufacturer
🇫🇮 Finland·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY and TÜV Rheinland LGA Products GmbH
CardiolyseECGSoftware
Device
EU MDD
·
Eu Md Class 2a
·Cardiolyse Oy·On the market·1 country
Kaiku Health
Device
EU MDD
·
Eu Md Class 2a
·Elekta Oy·No longer on the market·18 countries
ECG DATA MANAGEMENT SYSTEMS
Device
EU MDD
·
Eu Md Class 2a
·VitalSignum Oy·On the market·32 countries
Kuomed Oy
Importer
🇫🇮 Finland·21 Manufacturers
Kaiku Health
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Elekta Oy·1 device
CardiolyseECGSoftware
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Cardiolyse Oy·1 device
Beat2Phone ECG Service
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·VitalSignum Oy·1 device
HX 1070846-1
Certificate
IVDR QMS·Thermo Fisher Scientific Oy·TÜV Rheinland LGA Products GmbH
HD 601455120001
Certificate
MDD Annex II (excluding section 4)·VitalSignum Oy·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs
HD 60146563 0001
Certificate
MDD Annex II (excluding section 4)·Elekta Oy·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI