LC & LCMS compliant with In Vitro Diagnostic Regulation (IVDR)

Shimadzu offers Liquid Chromatography and Mass Spectrometry medical devices.

Medical doctor holding a baby

What does this mean to your lab?

These instruments are in compliance with the regulation "(EU) 2017/746" of the European Parliament. These instruments are produced under a manufacturing quality system (ISO-13485).

Shimadzu's CL Series

As one of the leaders supplying LC and LCMS solutions in the clinical field, Shimadzu Corporation offers a portfolio of LC (LC-40) and LCMS (8045/8050/8060/8060NX) instruments fulfilling the requirements of the new IVDR (Regulation (EU) 2017/746) which is valid from May 2022. The CL systems/modules (IVDR Class A) can be used by customers for diagnostic purposes.

CL Series Liquid Chromatograph and Mass Spectrometry Listed Devices
(for EU CE-IVD):

    Main Module P/N
LC Communications CBM-40 CL 228-45012-55
Nexera CL Liquid Chromatograph LC-40D X3 CL 228-65076-55
LC-40D XR CL 228-65000-55
LC-40B X3 CL 228-65078-55
Degassing Unit DGU-405 CL 228-65019-55
Nexera CL Autosampler SIL-40C X3 CL 228-65120-55
SIL-40C XR CL 228-65103-55
Nexera CL Column Oven CTO-40C CL 228-65202-55
Valve Unit FCV-S CL 228-65600-55
Nexera CL UV Detector SPD-40 CL 228-65312-55
LCMS Triple Quad LC-MS/MS LCMS-8045 CL 225-31400-55
LCMS-8050 CL 225-19600-55
LCMS-8060 CL 225-27800-55
LCMS-8060NX CL 225-41600-55
Automation CLAM automation module CLAM-2040 CL 241-18700-55
Software Software LC&LCMS LabSolutions CL Ver. 1.40 (DVD) 225-45811-55
Software LCMS LabSolutions Insight CL Ver. 1.1 (DVD) 225-45812-55
LabSolutions CL/LabSolutions Insight CL license ASSY 225-45813-55
Software LC LabSolutions CL Single LC (License) 223-63386-55
LabSolutions CL Add LC (License) 223-63387-55

NB: These instruments are only available in the target market where the conformity assessment procedure of the product (CE IVDR) is accepted.
These instruments are designed/developed, manufactured, installed and repaired under a certified Quality Management System according EN ISO 13485:2016 for medical devices and related services.

Top of This Page