13 results · 7ms · Sources: EU EUDAMED, US FDA

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Merlin Biomedical (Xiamen) Co., Ltd.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.

Myo Control

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

CLIA MYO Calibrator

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

CLIA MYO Control

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

MYO Assay Kit CLIA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

MYO Assay Kit CLIA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

SARS-CoV-2 Antigen Rapid Test Cassette

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

cTnl/ Myo/ CK-MB Control

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

Myoglobin (MYO) Kit (Latex Enhanced Immunoturbidimetric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zybio Inc.·1 device

Diagnostic Kit for Myoglobin (Myo) (Time-resolved Fluorescence Immunochromatographic Assay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

Diagnostic Kit for cTnI/Myo/CK-MB (Time-resolved Fluorescence Immunochromatographic Assay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

SARS-CoV-2 Antigen Rapid Test Cassette

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·1 device

CeCert/037/W/E.1

Certificate
IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI