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Device Explorer · FDA GUDID · GMDN 37606

Diagnostic x-ray system generator, portable

An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and

US‑registered devices54in commercial distribution
Companies12labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription43%Rx‑only share
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Share of device records

Poskom Co., Ltd.1833%
Shantou Institute Of Ultrasonic Instruments Co., Ltd.815%
Ecotron611%
Ajex Meditech Ltd59%
Digimed Co., Ltd.59%
First Source, Inc.36%
Yian Medical Technology (Haining) Co., Ltd.24%
Prognosys Medical Systems Private Limited24%

Top labelers

CompanyDevicesShare
Poskom Co., Ltd.1833%
Shantou Institute Of Ultrasonic Instruments Co., Ltd.815%
Ecotron611%
Ajex Meditech Ltd59%
Digimed Co., Ltd.59%
First Source, Inc.36%
Yian Medical Technology (Haining) Co., Ltd.24%
Prognosys Medical Systems Private Limited24%
Neuf Inc.24%
Job Corporation12%
Gemss Healthcare Co., Ltd.12%
Dexcowin Co., Ltd.12%

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

Brand names on the register (sample)

Yian Medical Technology (Haining) Co., Ltd.SIUIPORTAPRORAD ATLAS ULTRAPORTABLE PLUSPRORAD ATLAS ULTRAPORTABLEPortable X-ray UnitX-RAYXLITEAirRay-miniAirbile-100AirRayDiagnostic X-ray UnitPOSKOM Co., Ltd.iQ FlexDHX-70HXTG PRO 70

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

FDA product codes

CodeNameDevices
IZLSystem, X-Ray, Mobile47
EHDUnit, X-Ray, Extraoral With Timer6
MUHSystem,X-Ray,Extraoral Source,Digital1

GMDN & GCC registration

  • GMDN code 37606 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 43% · 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

Width (Millimeter) · 6Height (Millimeter) · 6Length (Millimeter) · 6Weight (Kilogram) · 6

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

How many diagnostic x-ray system generator, portable products are registered in the US?

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Diagnostic x-ray system generator, portable", from 12 companies. The largest labeler is Poskom Co., Ltd. with 33% of records.

Which FDA product codes apply?

IZL (System, X-Ray, Mobile), EHD (Unit, X-Ray, Extraoral With Timer), MUH (System,X-Ray,Extraoral Source,Digital)

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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