Medical measuring devices and rapid tests for diabetes self-monitoring and diagnostics for the German market

TESTAmed

Saarbrücken · Boppard-Bad SalzigNew on Amplifa

HRA 11544, AG SaarbrückenCommercial Register

Sebapharma GmbH & Co. KGParent Company

About TESTAmed

TESTAmed is a brand of Sebapharma GmbH & Co. KG based in Boppard-Bad Salzig. Sales responsibility lies with TREND Pharma GmbH in Saarbrücken. The portfolio comprises the DIABETES CARE and DIAGNOSTICS product groups: the TESTAmed GlucoCheck ADVANCE blood glucose meter with plasma-calibrated measurement, optional voice output in German and Turkish, Bluetooth and USB-C interface as well as PULSE2 technology for eliminating hematocrit interferences. In addition, test strips, control solutions, lancets, lancing devices, early pregnancy tests and ovulation tests are offered. The products are available nationwide in pharmacies, selected drugstores and in food retail as well as in the online shop. Own manufacturing is not documented; according to product documentation, the measuring system comes from BioCARE Corporation. The measurement accuracy of the blood glucose measuring system is documented according to ISO standard 15197:2015.

Site: Saarbrücken
Processes: Customer service and advice, Information material and blood glucose diaries, Online shop, Software/App for data management (GlucoCheck ADVANCE Management System, iFORA HM)
Materials: Measurement Accuracy Blood Glucose Measuring System
Certificates: ISO 15197:2015 (Measurement Accuracy)
Industries: Medical Technology/Medical Devices, Diabetes Care, Pregnancy Diagnostics, Medical Skin Care

01
Product development and qualification by the system manufacturer
02
Market responsibility and distribution via TREND Pharma GmbH resp. Sebapharma
03
Customer service, advice and information material
04
Distribution via pharmacies, drugstores, food retail and online shop
05
Software/App for data management (GlucoCheck ADVANCE Management System, iFORA

Product Groups and System Components

ISO 15197:2015

Measurement Accuracy Blood Glucose Measuring System

Certified measurement accuracy of the GlucoCheck ADVANCE blood glucose measuring system according to DIN EN ISO 15197:2013/15197:2015, verified by DEKRA Certification B.V.

Locations

Saarbrücken

Distribution (Legal Notice TREND Pharma GmbH)

Boppard - Bad Salzig

Contact and Service (Sebapharma GmbH & Co. KG)

Products

**GlucoCheck ADVANCE Blood Glucose Meter**Blood glucose measuring system · Diabetes Care

**GlucoCheck ADVANCE Test Strips**Test strips (0.5 µl blood sample) · Diabetes Care

**GlucoCheck ADVANCE Control Solution**Quality control · Diabetes Care

**Soft Lancets**Single-use lancets · Diabetes Care

**Lancing Device**Blood sampling · Diabetes Care

**Sensitive Early Pregnancy Test**Pregnancy diagnostics · Diagnostics

**Ovulation Test**Family planning · Diagnostics

Inside the production

Living with Diabetes – Self-Monitoring in Everyday Life

Industries

Medical Technology/Medical DevicesDiabetes CarePregnancy DiagnosticsMedical Skin Care

Additional services

Customer service and adviceInformation material and blood glucose diariesOnline shopSoftware/App for data management (GlucoCheck ADVANCE Management System, iFORA HM)

Quality

The GlucoCheck ADVANCE blood glucose measuring system achieves measurement accuracy according to ISO 15197:2015; certification evidence issued by DEKRA Certification B.V. for the measuring system of BioCARE Corporation. If the control solution deviates by more than 15% from the target value, the device is sent in for inspection.

Evidence	Saarbrücken
ISO 15197:2015 (Measurement Accuracy)