β-CTx (CLIA)

Device Name

β-CTx (CLIA)、β-CTx Calibrators

Model / Reference

105-044298-00、105-044299-00、105-045113-00, 105-044298-00

Primary DI / UDI-DI

06903053089920

Basic UDI-DI

69449040AB74000635U

EMDN Code

W0102060304 Cross-linked c-telopeptides

Device Class

Class B

Market of Registration

Germany

EUDAMED SRN

CN-MF-000014156

Authorised representative

Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

• HBsAg Positive Control

  Class D

  CE/IVDR V76 044751 0357 Active Valid to Oct 2031

• DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

  Class II

  FDA 510(k) K182636 Active Cleared 10 Jan 2019

• Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System

  Class II

  FDA 510(k) K221300 Active Cleared 29 Sep 2022

• Diagnostic Ultrasound System (Resona I10W)

  Class II

  FDA 510(k) K261617 Active Cleared 8 Oct 2026

• Diagnostic Ultrasound System

  Class IIa

  CE/MDR

• Neutralization Buffer

  Class A

  CE/IVDR

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