1984-MDD-17-461

Certificate

MDD Annex II (excluding section 4)·KOEK BİYOTEKNOLOJİ BİYOMÜHENDİSLİK VE MEDİKAL HİZ. SAN. TİC. A.Ş.·Kiwa Belgelendirme Hizmetleri A.Ş.·6 Basic UDI-DIs

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification

FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

2021-MDD/QS-022

Certificate

MDD Annex II (excluding section 4)·OR-CZ spol. s r.o.·3EC International a.s.·1 Basic UDI-DI

HASVET MEDİKAL YAZILIM SAĞ. HİZ. SAN. VE TİC. A.Ş.

Importer

🇹🇷 Türkiye

Galdent CZ s.r.o.

Authorized representative

🇨🇿 Czechia·1 Manufacturer

STERİLİZASYON MEDİKAL SAĞ. HİZ. GIDA SAN. VE TİC. LTD. ŞTİ.

Importer

🇹🇷 Türkiye

HOZ MEDI WERK Produktions- und Vertriebs GmbH & Co. KG

Importer

🇩🇪 Germany

Human Care HC AB

Authorized representative

🇸🇪 Sweden

EUROMEDISHOP

FDA registration

EUROMEDISHOP·13 products·🇫🇷 France

Clinitek Status+

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD·13 products·🇬🇧 United Kingdom

Clinitek Status+

FDA registration

Siemens Healthcare Diagnostics Inc·13 products·🇺🇸 United States

Clinitek Status+

FDA registration

Siemens Healthcare Diagnostics Inc.·13 products·🇺🇸 United States

Medikon Sağlık Turizm Seyahat Dan. Hiz. İth. İhr. ve Tic. Ltd. Şti.

Importer

🇹🇷 Türkiye

Clinitek Status Connector

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414607962·The CLINITEK Status Connector is intended for u...

Global Regulatory Solutions HC B.V.

Authorized representative

🇳🇱 Netherlands·1 Manufacturer·1 Device

STERİLİZASYON MEDİKAL SAĞ. HİZ. GIDA SAN. VE TİC. LTD. ŞTİ.

Authorized representative

🇹🇷 Türkiye

CLINITEK Status® Connector

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414571263·The CLINITEK Status® Connector is intended for ...

CLINITEK Status®+ Analyzer

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414572314·The CLINITEK Status+ Urine Chemistry Analyzer i...