BE/2400000082

Certificate

IVDD Annex III Section 6·D-tek s.a.·SGS United Kingdom Limited·1 Basic UDI-DI

No.2020-IVD/QS-008

Certificate

IVDD Annex IV (excluding sections 4, 6)·CTK Biotech Inc.·3EC International a.s.·1 Basic UDI-DI

DKT WomanCare Global Services SAS

Importer

🇫🇷 France·1 Manufacturer

DTM Natura d.o.o.

Authorized representative

🇸🇮 Slovenia

Elos Accurate Customized Abutment, Elos Prosthetic Screw

FDA 510(k)

FDA Class 2 ·Dental

Ambu® aScope™ Colon; Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRASOUND SCANNER, TYPE 2400

FDA 510(k)

FDA Class 2 ·Radiology

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TRIOS Ready Tip

FDA 510(k)

FDA Class 2 ·Dental

Hydrozid Precise

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PEDIATRIC ARTERIAL CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

EmbryoSlide+ ic8 dish

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ULTRASOUND SCANNER PRO FOCUS, MODEL 2202

FDA 510(k)

FDA Class 2 ·Radiology

ICS Dizcovery (1091)

FDA 510(k)

FDA Class 2 ·Neurology

PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRASOUND SCANNER MINI FOCUS, MODEL 1402

FDA 510(k)

FDA Class 2 ·Radiology

K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION

FDA 510(k)

FDA Class 2 ·Neurology

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535

FDA 510(k)

FDA Class 2 ·Radiology

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)

FDA 510(k)

FDA Class 2 ·Hematology