CORONAVIRUS [obsolete from 2025-01-01]

Device

EU IVDD · Eu Ivd Self Testing ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·On the market

Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）

Device

EU IVDD · Eu Ivd Self Testing ·Hangzhou Realy Tech Co.,Ltd.·On the market

SARS-CoV-2 Antigen Rapid Test Cassette

Device

EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·On the market

MARQUETTE 1200 DEFIBRILLATION PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

AST (GOT) - ASPARTATE AMINOTRANSFERASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UREA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALT (GPT) - ALANINE AMINOTRANSFERASE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RANDOX COMPLEMENT C4

FDA 510(k)

FDA Class 2 ·Immunology

CK-NAC ACTIVATED KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URIC ACID ENZYMATIC COLORIMERIC KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TRIGLYCERIDES GPO-PAP

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TOTAL CO2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GAMMA-GT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CHOLESTEROL ENZYMATIC ENDPOINT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT

FDA 510(k)

FDA Class 2 ·Ophthalmic

ALKALINE PHOSPHATASE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EXHALYZER D

Basic UDI-DI

EU MDR · Eu Md Class 2a ·ECO PHYSICS AG·1 device

TAiMA M-ECO

Basic UDI-DI

EU MDR · Eu Md Class 1 ·DIETZ GmbH·1 device

Turbine Eco Line

Basic UDI-DI

EU MDR · Eu Md Class 2a ·MK-dent GmbH·1 device

SÜDA V Eco

Basic UDI-DI

EU MDR · Eu Md Class 2a ·IONTO Health & Beauty GmbH·1 device