9 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Ai-Pex (EDGEAPEX)
Device
EU MDR
·
Eu Md Class 2a
·Guilin Woodpecker Medical Instrument Co., Ltd.·On the market·32 countries
Ai-Pex
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Guilin Woodpecker Medical Instrument Co., Ltd.·1 device
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
Apex Locator
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Guilin Woodpecker Medical Instrument Co., Ltd.·9 devices
Apex Locator
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Guilin Refine Medical Instrument Co.,Ltd.·1 device
Spatz3 Adjustable Balloon System
Device
EU MDD
·
Eu Md Class 2b
·Spatz FGIA Inc.·On the market·20 countries
Endo Motor and Apex Locator Unit
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Guilin Woodpecker Medical Instrument Co., Ltd.·10 devices
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