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EU IVDR Kit Devices

View 3088 EU IVDR Kit devices on BEUDAMED, the Better Database on Medical Devices. Kits under the IVDR are in vitro diagnostic products composed of multiple components supplied together to perform a diagnostic function, such as reagent sets, controls, or calibrators. The BEUDAMED listing helps users identify market status, manufacturer details, and the declared intended use for each kit.

IVDR requirements for kits include demonstrated performance evaluation, appropriate labeling and instructions for use, and conformity assessment according to their risk class. Manufacturers must maintain technical documentation, implement post-market surveillance, and apply UDI where applicable to ensure traceability. Searching BEUDAMED entries for kits supports laboratories, clinicians, and procurement teams in confirming compliance and suitability for diagnostic workflows.

MR Serum Standard、MR Urine Standard、MR Urine Quality Control

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Prealbumin Kit (Turbidimetry Method)、Prealbumin Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

CO2 and TBA Multi Control

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device

Myoglobin Kit (Particle-enhanced Immunoturbidimetric Assay Method)、MYO Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices

Cystatin C Kit (Latex Immunoturbidimetric Method) 、Cystatin C Calibrator、Cystatin C Control

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·5 devices

Cholinesterase (CHE) Kit (DGKC Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Lipids Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device

Specific Proteins Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device

β-Hydroxybutyrate Kit (Enzymatic Colorimetric Method)、β-HB Calibrator、β-HB Control

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·5 devices

Glucose-6-Phosphate Dehydrogenase Kit (UV Enzymatic Method)、G6PD Control

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices