HD 1809159

Certificate

MDD Annex II (excluding section 4)·GHC Global Health Care GmbH·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

System, Test, Her-2/Neu, Ihc

FDA classification

FDA Class 3 ·System, Test, Her-2/Neu, Ihc

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AICD, VENTAK PRX II AICD, VENTAK PRX III AICD, VENTAK MINI AICD, VENTAK MINI HC AICD, VENTAK II AICD

GHC German Health Care GmbH

Importer

🇩🇪 Germany·7 Manufacturers

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY ASPRICE HC AND ASPIRESR, DEMIPULSE AND DEMIPULSE DUO, PULSE AND PULSE DUO GENERATORS; VNS THERAPY PERENNIAD

PHC Europe B.V.

Authorized representative

🇳🇱 Netherlands·3 Manufacturers·12 Devices

JTC Diagnosemittel GmbH

Authorized representative

🇩🇪 Germany

Titrimetric Permanganate And Bromophenol Blue, Calcium

FDA classification

FDA Class 2 ·Titrimetric Permanganate And Bromophenol Blue, Calcium

System, Test, Systemic Lupus Erythematosus

FDA classification

FDA Class 2 ·System, Test, Systemic Lupus Erythematosus

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY PULSE & PULSE DUO GENERATORS,VNS THERAPY DEMIPULSE AND DEMIPULSE DUO GENERATORS,VNS THERAPY ASPIRE HC GENER

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

FDA classification

FDA Class 2 ·System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·C-KIT PHARMDX

RET-SEARCH(II)

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·SYSMEX CORPORATION·1 device

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification

FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Claudin 18

FDA Pre-Market Approval

FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay