Consulting Wallah › Device Explorer › Equipment & monitoring › X-ray film cassette, manual
Device Explorer · FDA GUDID · GMDN 35437

X-ray film cassette, manual

A device used in medical imaging applications to shield x-ray film from exposure to room light during transport and insertion into a diagnostic imaging system, film formatter, or film processor. It is typically designed for use with a particular imaging system

US‑registered devices90in commercial distribution
Companies6labelers on GUDID
Single‑use33%of device records
Sterile1%labelled sterile
Prescription62%Rx‑only share
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Share of device records

Agfa5561%
Plasdent Corporation1921%
American Medical & Hospital Supply Co., Inc.56%
Digiray Corp.56%
Jpi Healthcare. Co., Ltd.56%
Stradis Medical, Llc11%

Top labelers

CompanyDevicesShare
Agfa5561%
Plasdent Corporation1921%
American Medical & Hospital Supply Co., Inc.56%
Digiray Corp.56%
Jpi Healthcare. Co., Ltd.56%
Stradis Medical, Llc11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Green RE 400 SpeedGreen RE 100 SpeedCURIX ORTHO FASTAGFA CPB 400AGFA CPB 200CURIX ORTHO REGULARCURIX ORTHO MEDIUMMAMORAY DETAIL RCURIX OPTHOS HMAMORAY HDMAMORAY HD SPlasdentAmtouch Barrier EnvelopesSTRADISCassette 18cmx24cm(IP 18cmx24cm)KitCassette 24cmx30cm(IP 24cmx30cm)Kit

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

FDA product codes

CodeNameDevices
IXACassette, radiographic film47
PEMDental Barriers And Sleeves16
IZHSystem, x-ray, mammographic8
EGZHolder, Film, X-Ray5
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)5
IXACassette, Radiographic Film5

GMDN & GCC registration

  • GMDN code 35437 · non‑implantable
  • Single‑use 33% · sterile 1% · Rx‑only 62% · 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 (Centimeter) · 57Length (Centimeter) · 57Weight (Kilogram) · 5Length (Inch) · 4Width (Inch) · 3

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

How many x-ray film cassette, manual products are registered in the US?

90 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "X-ray film cassette, manual", from 6 companies. The largest labeler is Agfa with 61% of records.

Which FDA product codes apply?

IXA (Cassette, radiographic film), PEM (Dental Barriers And Sleeves), IZH (System, x-ray, mammographic), EGZ (Holder, Film, X-Ray)

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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