MassLynx

Device Name

Waters IVD Systems

Model / Reference

667004007

Primary DI / UDI-DI

00816776020322

Basic UDI-DI

081677602MSTKPF0802BU

EMDN Code

W020303 Mass - spectrometry system

Device Class

Class A

Market of Registration

Netherlands

EUDAMED SRN

US-MF-000025801

Authorised representative

Emergo Europe B.V. NL-AR-000000116

• MassTrak™

  Class B

  CE/IVDR

• MassTrak Immunosuppressants Kit

  Class II

  CE/IVDR FDA 510(k) K063868 Active Cleared 25 May 2007

• 2700 Sample Manager

  Class I

  FDA 510(k) K980180 Active Cleared 12 Feb 1998

• Alliance 2690 Separations Module

  Class I

  FDA 510(k) K961557 Active Cleared 5 Jul 1996

• Waters 474 Scanning Flourescence Detector (474)

  Class I

  FDA 510(k) K962574 Active Cleared 22 Jul 1996

• Waters 515 Hplc Pump (515)

  Class I

  FDA 510(k) K964588 Active Cleared 29 Nov 1996

See all devices from Waters Corporation →