62 results
·
9ms
·
Sources: EU EUDAMED, US FDA
FCU Co., Ltd.
Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
ASAHI ZenyteEX PTCA GUIDING CATHETER
Device
EU MDD
·
Eu Md Class 3
·ASAHI INTECC CO., LTD.·On the market·30 countries
SBL-2™
Device
EU MDD
·
Eu Md Class 2b
·Lenstec (Barbados) Inc.·On the market·1 country
Polydentia SA
Manufacturer
🇨🇭 Switzerland·38 Basic UDI-DIs·385 Devices·9 Importers·SGS Belgium NV
JADE PTA (JADE 18 OTW)
Device
EU MDD
·
Eu Md Class 2a
·OrbusNeich Medical (Shenzhen) Co.,Ltd·On the market·1 country
SIORA
Device
EU MDD
·
Eu Md Class 2b
·SIORA SURGICALS PVT. LTD.·On the market·1 country
OK REAL RESIN BRACKET
Device
EU MDD
·
Eu Md Class 2a
·Osstem Orthodontics Inc.·No longer on the market
Sonovation1L, SOFRA1L, SonoInfra1L, Dr.SAFE, ACUFRIEND, ACUGUIDE,ACUWARY, AcuViz Pocket, Sono Cloud 1, eZono1000, eZ1L
Device
EU MDD
·
Eu Md Class 2a
·FCU Co., Ltd.·On the market·1 country
F-Splint-Aid Slim
Device
EU MDD
·
Eu Md Class 2a
·Polydentia SA·No longer on the market·32 countries
Fiber-Splint one-layer
Device
EU MDD
·
Eu Md Class 2a
·Polydentia SA·No longer on the market·32 countries
F-Splint-Aid
Device
EU MDD
·
Eu Md Class 2a
·Polydentia SA·No longer on the market·32 countries
Fiber-Splint ortho evolution
Device
EU MDD
·
Eu Md Class 2a
·Polydentia SA·No longer on the market·32 countries
fiber-Splint ML multi-layer
Device
EU MDD
·
Eu Md Class 2a
·Polydentia SA·No longer on the market·32 countries
F-Splint-Aid & Slim
Device
EU MDD
·
Eu Md Class 2a
·Polydentia SA·No longer on the market·32 countries
Fiber bond
Device
EU MDD
·
Eu Md Class 2a
·Polydentia SA·No longer on the market·32 countries
ASAHI ZenyteEX PTCA GUIDING CATHETER
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·ASAHI INTECC CO., LTD.·1 device
SBL-2
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Lenstec (Barbados) Inc.·1 device
SC1 Handheld ultrasound imaging system
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·FCU Co., Ltd.·1 device
1434-MDD-365/2021
Certificate
MDD Annex II (excluding section 4)·FCU Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
F-Splint-Aid Slim
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Polydentia SA·1 device