8 results
·
7ms
·
Sources: EU EUDAMED, US FDA
DEXLEVO INC.
Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·1 Importer·Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi
H&abyz
Manufacturer
🇰🇷 South Korea·3EC International a.s.
BNC KOREA, Inc.
Manufacturer
🇰🇷 South Korea·60 Basic UDI-DIs·60 Devices·3EC International a.s., 3EC International a.s., and 3EC International a.s.
GOURI
Device
EU MDD
·
Eu Md Class 3
·DEXLEVO INC.·On the market·1 country
2024-MDR/QS-027
Certificate
MDR QMS·H&abyz·3EC International a.s.
2023-MDR/QS-004
Certificate
MDR QMS·BNC KOREA, Inc.·3EC International a.s.
CE-MDD-0115/03/2021/01
Certificate
MDD Annex II (excluding section 4)·DEXLEVO INC.·Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi·1 Basic UDI-DI
GOURI
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·DEXLEVO INC.·1 device