Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Radioimmunoassay, Cyclic Amp

FDA classification

FDA Class 2 ·Radioimmunoassay, Cyclic Amp

Radioimmunoassay, Cyclic Gmp

FDA classification

FDA Class 2 ·Radioimmunoassay, Cyclic Gmp

One Step Amphetamine (AMP)Test Device (Hair)(Immunofluorescence )

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device

Alkaline Phosphatase Kit (Kinetic Method with NPP-AMP)

Basic UDI-DI

EU IVDD · Eu Ivd General ·MedicalSystem Biotechnology Co., Ltd.·1 device

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS)

One Step Amphetamine (AMP) Test Kit (Urine) (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device

One Step Amphetamine (AMP) Test Kit(Hair) (Colloidal Gold )

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device

17584

Certificate

MDD Annex II (excluding section 4)·EMED Technologies Corporation·GMED SAS·1 Basic UDI-DI

Filtration Stand Electric

Basic UDI-DI

EU MDR · Eu Md Class 1 ·STRUB GMBH·1 device

CE 94777

Certificate

MDD Annex II (excluding section 4)·Submarine Manufacturing & Products Ltd·BSI Group The Netherlands B.V.·1 Basic UDI-DI

Alkaline Phosphatase Reagent Kit (NPP-Kinetic Substrate-AMP Buffer Method)

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·5 devices

Easy Amp Real-time Fluorescence Isothermal Detection System (HWTS 1600)

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·3 devices

Alkaline Phosphatase (ALP) Assay Kit (NPP Substrate-AMP Buffer Method)

Basic UDI-DI

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

TMH Medizinhandel GmbH & Co. KG

Importer

🇩🇪 Germany·1 Manufacturer

Exercise Equipment, Powered, Emg-Triggered

FDA classification

FDA Class 2 ·Exercise Equipment, Powered, Emg-Triggered

MDD-202

Certificate

MDD Annex II (excluding section 4)·IMP - PIEZOTEHNOLOGIJA DOO BEOGRAD·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ·1 Basic UDI-DI

3M Deutschland GmbH (Dental)

Importer

🇩🇪 Germany·1 Manufacturer

Endoscopic Morcellator Gastroenterology

FDA classification

FDA Class 2 ·Endoscopic Morcellator Gastroenterology

STUDIO EMI SRL

Authorized representative

🇷🇴 Romania