10 results
·
8ms
·
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
Spatz3 Adjustable Balloon System
Device
EU MDD
·
Eu Md Class 2b
·Spatz FGIA Inc.·On the market·20 countries
Human Xtensions Ltd.
Manufacturer
🇮🇱 Israel·2 Basic UDI-DIs·3 Devices·1 Importer
Spatz3 Adjustable Balloon System Insertion Kit
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Spatz FGIA Inc.·1 device
HandX Needle Holder
Device
EU MDR
·
Eu Md Class 2a
·Human Xtensions Ltd.·On the market·5 countries
HandX Handpiece
Device
EU MDR
·
Eu Md Class 2a
·Human Xtensions Ltd.·On the market·5 countries
HandX Self- righting Needle Holder
Device
EU MDR
·
Eu Md Class 2a
·Human Xtensions Ltd.·On the market·5 countries
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
HandX Needle Holder
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Human Xtensions Ltd.·2 devices
HandX Handpiece
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Human Xtensions Ltd.·1 device