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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER

HCP Business GmbH

Importer

🇩🇪 Germany·2 Manufacturers

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

Canbolat Vertriebsgesellschaft mbH

Importer

🇩🇪 Germany·1 Manufacturer

Human Care HC AB

Importer

🇸🇪 Sweden

Rubicon Technical Limited

Authorized representative

🇳🇱 Netherlands·3 Manufacturers

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & HIGH RISK HPV DNA TEST

PyroCarbon PIP Total Joint System

FDA UDI

Smith & Nephew, Inc.·00885556858479·PIP DISPOSABLE PACK FOR LINVATEC/HALL

PyroCarbon PIP Total Joint System

FDA UDI

Smith & Nephew, Inc.·00885556858486·PIP DISPOSABLE PACK FOR STRYKER

Test, Immunoassay, Biosensor, Hcg

FDA classification

FDA Class 2 ·Test, Immunoassay, Biosensor, Hcg

301081783

Certificate

MDD Annex V·President Dental GmbH·ENTE CERTIFICAZIONE MACCHINE SRL·14 Basic UDI-DIs

5-926+200-2105

Certificate

MDD Annex II (excluding section 4)·FIXIER SA DE CV·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)·1 Basic UDI-DI

HaB GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer·2 Devices

Cb Amateur Radio

FDA classification

FDA Not Classified ·Cb Amateur Radio