Medical Grade Monitor

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Device Name

Medical Grade Monitor

Model / Reference

S3281P, S2785P(UNT-18-004)

Primary DI / UDI-DI

06970027821589

Basic UDI-DI

697002782001FH

EMDN Code

Z11900801 Bioimaging diagnostic report viewing monitors

Device Class

Class I

EU market of registration

Austria

EUDAMED SRN

CN-MF-000008774

Authorised representative

SUNGO Europe B.V. NL-AR-000000247

• Medical Grade Monitor

  Class I

  CE/MDR

• 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)

  Class II

  FDA 510(k) K231026 Active Cleared 18 Aug 2023

• 6MP Color LCD Monitor (C61W+)

  Class II

  FDA 510(k) K182291 Active Cleared 20 Nov 2018

• 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

  Class II

  FDA 510(k) K233119 Active Cleared 28 Dec 2024

• 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)

  Class II

  FDA 510(k) K233897 Active Cleared 6 Feb 2024

• 3MP Grayscake LCD Display

  Class II

  FDA 510(k) K140103 Active Cleared 14 Feb 2014

See all devices from Shenzhen Beacon Display Technology Co., Ltd. →