HISTOLS-DAB

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Histopathology Ltd.·1 device

Xpert® Xpress CoV-2 plus

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)

FDA 510(k)

FDA Class 2 ·Microbiology

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

FDA 510(k)

FDA Class 2 ·Microbiology

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire COVID-19 Test 2

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire COVID-19 Test 2

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima SARS-CoV-2 Assay

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa COVID-19 Direct

FDA 510(k)

FDA Class 2 ·Microbiology

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE GLUCOSE SENSORS

Eyenuk, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·Intertek Medical Notified Body AB and INTERTEK SEMKO AB

Innoventa Medica ApS

Manufacturer

🇩🇰 Denmark·3 Basic UDI-DIs·8 Devices·Intertek Medical Notified Body AB, Intertek Medical Notified Body AB, and Intertek Medical Notified Body AB

GENJECT SAGLIK URUNLERI VE KIMYA SAN. VE TIC. A.S.

Manufacturer

🇹🇷 Türkiye·6 Basic UDI-DIs·6 Devices·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Incuram

Manufacturer

🇰🇷 South Korea·15 Basic UDI-DIs·15 Devices·1 Importer·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Alternatif Medikal San.Tic.Ltd.Şti.

Manufacturer

🇹🇷 Türkiye·3 Basic UDI-DIs·3 Devices·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

PERMED SAGLIK URUNLERI GIDA TEKSTIL HAYVANCILIK INSAAT SANAYI VE TICARET LIMITED SIRKETI

Manufacturer

🇹🇷 Türkiye·2 Basic UDI-DIs·2 Devices·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

ALEDA MAKİNA SANAYİ DIŞ TİCARET LİMİTED ŞİRKETİ

Manufacturer

🇹🇷 Türkiye·26 Basic UDI-DIs·26 Devices·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.