62 results · 9ms · Sources: EU EUDAMED, US FDA

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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