11 results
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8ms
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Sources: EU EUDAMED, US FDA
Spatz FGIA Inc.
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
ECG Recorder
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Shenzhen Viatom Technolog Co, Ltd·1 device
ECG Recorder
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Shenzhen Viatom Technolog Co, Ltd·4 devices
Dynamic ECG Recorder
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Shenzhen Viatom Technolog Co, Ltd·6 devices
QT ECG Recorder
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·QT Medical, Inc.·1 device
PCA-A300 ECG Cable Converter
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·QT Medical, Inc.·1 device
Blood Pressure Monitor with ECG
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Shenzhen Viatom Technolog Co, Ltd·1 device
QT ECG Disposable Electrode Strip
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·QT Medical, Inc.·14 devices
Spatz3 Adjustable Balloon System
Device
EU MDD
·
Eu Md Class 2b
·Spatz FGIA Inc.·On the market·20 countries
Spatz3 Adjustable Balloon System Insertion Kit
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Spatz FGIA Inc.·1 device
170222 QS/NB
Certificate
MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI