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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)

JPC d.o.o.

Importer

🇸🇮 Slovenia

JSC ANALIZE

Importer

🇱🇹 Lithuania·1 Manufacturer

JPC UG

Importer

🇩🇪 Germany

Curing Light Device

Basic UDI-DI

EU MDR · Eu Md Class 1 ·JC ORTHOHEAL PRIVATE LIMITED·2 devices

FlexiOH - Light Cured Polymer Immobilizer

Basic UDI-DI

EU MDR · Eu Md Class 1 ·JC ORTHOHEAL PRIVATE LIMITED·41 devices

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)

EVA Vitrectomy Pack VGPC Input 20G

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872034652·

EVA Vitrectomy Pack VGPC Input 20G

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872030678·

EVA NEXUS™, Phaco vitrectomy system including laser with SMA connector

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872034447·

EVA Nexus™ Irrigation Tubing

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872032986·

EVA Nexus™ Aux. Aspiration Tubing

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872032979·

EVA Custom TDC Vitrectomy Pack VGPC Input 25G

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872031347·

EVA Custom TDC Vitrectomy Pack VGPC Input 27G

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872032702·

EVA Custom TDC Vitrectomy Pack VGPC Input 25G

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872021294·

EVA, combined machine including Laser (DORC connector)

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872029993·

EVA TDC Vitrectomy Pack VGPC Input 27G, Ultra short

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872031422·

EVA Custom TDC Vitrectomy Pack VGPC Input 23G

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872031026·

EVA Vitrectomy Pack Gravity Input 23G

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872032122·