CareTec, Inhaber Dipl.-Ing. Hans-Georg Klose e.K

Manufacturer

🇩🇪 Germany

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

Quo-Test A1c System

FDA 510(k)

FDA Class 2 ·Hematology

Hemo Control (optional Add Pack Hemo Control DM)

FDA 510(k)

FDA Class 2 ·Hematology

EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W

FDA 510(k)

FDA Class 2 ·Hematology

DiaSpect Tm, DiaSpect Tm Cuvettes

FDA 510(k)

FDA Class 2 ·Hematology

CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE

FDA 510(k)

FDA Class 1 ·Hematology

VACUUM CUP (004SD)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

REHASTIM 2, REHAMOVE 2

FDA 510(k)

FDA Class 2 ·Neurology

SWIFT DELIVERY PRODUCT #300

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SWIFT LOW PROFILE CUP (PRO CUP)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RehaStim 2

FDA 510(k)

FDA Class 2 ·Neurology

REHASTIM & REHAMOVE

FDA 510(k)

FDA Class 2 ·Neurology

REHASTIM 2, ERIGOPRO (FES)

FDA 510(k)

FDA Class 2 ·Neurology

RESTLESS LEG DEVICE

FDA 510(k)

FDA Class 1 ·Physical Medicine

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·EBK RIA ASSAY/ETI-EBK

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-AB-EBK PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-EBK PLUS ASSAY