ARIX Ankle Fibula Hook Plate System

FDA registration

JEIL MEDICAL CORPORATION·1 product·🇰🇷 South Korea

Lactate Dehydrogenase (LDH) Kit (Rate Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zybio Inc.·1 device

Alanine Aminotransferase Kit (UV-LDH Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

Adhesive Electrodes for TENS

Basic UDI-DI

EU MDR · Eu Md Class 1 ·JKH Health Co., Ltd.·39 devices

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)

FDA UDI

EUROIMMUN Medizinische Labordiagnostika AG·04049016124887·

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)

FDA UDI

EUROIMMUN Medizinische Labordiagnostika AG·04049016124894·

HYDRASYS ISO-LDH, ISO-PAL, CHOL ACCESSORIES

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·sebia·1 device

Proov

FDA UDI

Mfb Fertility, Inc.·00850035206065·A comprehensive at home fertility test that mea...

Proov

FDA UDI

Mfb Fertility, Inc.·00850035206157·A comprehensive screening kit that analyzes key...

LCH MEDICAL PRODUCTS

Importer

🇫🇷 France

LKB Vertriebs Ges.m.b.H

Importer

🇦🇹 Austria·1 Manufacturer

Lactate Dehydrogenase (LDH) Assay Kit (Lactate Substrate Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Proov

FDA UDI

Mfb Fertility, Inc.·00850035206126·At home fertility test that measures all 4 cycl...

LBH Advanced BioServices AB

Importer

🇸🇪 Sweden·2 Manufacturers

Myocardial Enzyme Reagent Kit (CK, CK-MB, LDH, α -HBDH)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Changsha Sinocare Inc.·1 device

Detection Kit for Falciparum Malaria/Vivax Malaria LDH (Immunochromatography Assay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice HRD CDx

Detection Kit for Falciparum Malaria/Vivax Malaria LDH (Colloidal Gold Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice CDx

RADICHAMP

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·KH Medical Co., Ltd.·1 device