Alpha fetoprotein Test (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2

Basic UDI-DI

EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Real-time fluorescent RT-PCR kit for detecting 2019-nCoV

Basic UDI-DI

EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Nucleic Acid Extraction Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·1 device

HGI Europe Oy

Importer

🇫🇮 Finland·2 Manufacturers

Latvia MGI Tech

Importer

🇱🇻 Latvia·2 Manufacturers

MEGINE

FDA registration

MEGINE INDUSTRIES SDN BHD·1 product·🇲🇾 Malaysia

MEGINE

FDA registration

MEGINE INDUSTRIES SDN BHD·1 product·🇲🇾 Malaysia

Latvia MGI Tech SIA

Authorized representative

🇱🇻 Latvia·1 Manufacturer

colonic FTRD Set

FDA UDI

Ovesco Endoscopy AG·04260206311010·The colonic FTRD Set is a novel tool for diagno...

FTRD System Set

FDA UDI

Ovesco Endoscopy AG·04260206310556·The FTRD System Set is a novel tool for diagnos...

diagnostic FTRD Set

FDA UDI

Ovesco Endoscopy AG·04260206311072·The diagnostic FTRD Set is a novel tool for dia...

1434-IVDD-011/2022

Certificate

IVDD Annex III Section 6·BGI EUROPE A/S·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

MGI Tech FR, SARL

Importer

🇫🇷 France

Time-of-Flight Mass Spectrometer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Wuhan BGI Biomedical Engineering Co., Ltd.·1 device

Automatic Chemiluminescence Immunoassay Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Wuhan BGI Biomedical Engineering Co., Ltd.·1 device

Automatic Chemiluminescence Immunoassay Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Wuhan BGI Biomedical Engineering Co., Ltd.·1 device

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP,Z,Z NOVUS,SP NOVUS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS