MED-RAS GmbH Regulatory Affairs Service

Authorized representative

🇩🇪 Germany·18 Manufacturers·235 Devices

Protective Barrier Enclosure

FDA classification

FDA Not Classified ·Protective Barrier Enclosure

CJ Managementservice

Authorized representative

🇩🇪 Germany

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

FDA classification

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

Piccolo MetLyte Plus CRP

FDA UDI

ABAXIS, INC.·EABA40000341·The Piccolo® MetLyte Plus CRP reagent disc, use...

HC ITALIA SRL

Importer

🇮🇹 Italy

Zuccato HC Srl

Importer

🇮🇹 Italy

HC PHARMA S.r.l.

Importer

🇮🇹 Italy

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

Human Care HC AB

Importer

🇸🇪 Sweden

Piccolo Renal Function Panel

FDA UDI

ABAXIS, INC.·EABA40000271·The Piccolo® Renal Function Panel, used with th...

Piccolo Basic Metabolic Panel Plus

FDA UDI

ABAXIS, INC.·EABA40000311·The Piccolo® Basic Metabolic Panel Plus, used w...

Global Regulatory Solutions HC B.V.

Importer

🇳🇱 Netherlands·1 Manufacturer

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

Clinitek Status Connector

FDA UDI

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