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Device Explorer · FDA GUDID · GMDN 36615

Image display unit, monochrome

An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices)

US‑registered devices53in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Eizo Corporation3668%
Nanjing Jusha Display Technology Co., Ltd.611%
Jvc Kenwood Corporation59%
Qingdao Hisense Medical Equipment Co., Ltd.36%
Seca Gmbh & Co. Kg36%

Top labelers

CompanyDevicesShare
Eizo Corporation3668%
Nanjing Jusha Display Technology Co., Ltd.611%
Jvc Kenwood Corporation59%
Qingdao Hisense Medical Equipment Co., Ltd.36%
Seca Gmbh & Co. Kg36%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

JUSHAHisenseRadiForce®seca 496seca 495 rseca 495JVC

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
PGYDisplay, Diagnostic Radiology51
LLZSystem, Image Processing, Radiological23
FRWSCALE, PATIENT3

GMDN & GCC registration

  • GMDN code 36615 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 75% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many image display unit, monochrome products are registered in the US?

53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Image display unit, monochrome", from 5 companies. The largest labeler is Eizo Corporation with 68% of records.

Which FDA product codes apply?

PGY (Display, Diagnostic Radiology), LLZ (System, Image Processing, Radiological), FRW (SCALE, PATIENT)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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