Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENTS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS(ELEMENT PLUS /PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Assure Tech. (Hangzhou) Co., Ltd.

Manufacturer

🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

SkinVision Service

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Skin Vision BV·1 device

MijnVital10

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Simal Beheer B.V.·1 device

BXTAccelyon NL B.V.

Importer

🇳🇱 Netherlands

simovision bv NL

Importer

🇳🇱 Netherlands

Zybio Inc.

Manufacturer

🇨🇳 China·147 Basic UDI-DIs·212 Devices·3 Importers

Hangzhou Alltest Biotech.Co.,Ltd.

Manufacturer

🇨🇳 China·119 Basic UDI-DIs·171 Devices·32 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

WenZhou Emma Optics Co.,Ltd.

Manufacturer

🇨🇳 China

Lithotripsy System

Basic UDI-DI

EU MDR · Eu Md Class 1 ·G-FLEX FLEXIBLE INSTRUMENTS EUROPE·2 devices

Centrifuge 5804; Centrifuge 5804R; Centrifuge 5810; Centrifuge 5810R

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Eppendorf SE·16 devices

RB NL Brands B.V

Importer

🇳🇱 Netherlands·2 Manufacturers

Salts Healthcare NL B.V.

Importer

🇳🇱 Netherlands

Changsha Sinocare Inc.

Manufacturer

🇨🇳 China·67 Basic UDI-DIs·68 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Changsha Sinocare Inc.

Manufacturer

🇨🇳 China·1 Importer·TÜV Rheinland LGA Products GmbH