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Device Explorer · FDA GUDID · GMDN 36843

Mobile examination/treatment room light

A mobile device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mou

US‑registered devices155in commercial distribution
Companies17labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription26%Rx‑only share
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Share of device records

Medical Illumination International Inc.3422%
Maquet Sas2818%
Sunnex2013%
Acem Spa1510%
Welch Allyn, Inc.128%
Aadco Medical, Inc.96%
Heine Optotechnik Gmbh & Co. Kg75%
Huot Instruments, Llc75%

Top labelers

CompanyDevicesShare
Medical Illumination International Inc.3422%
Maquet Sas2818%
Sunnex2013%
Acem Spa1510%
Welch Allyn, Inc.128%
Aadco Medical, Inc.96%
Heine Optotechnik Gmbh & Co. Kg75%
Huot Instruments, Llc75%
Dr Vampa S.R.L.53%
Karl Storz Gmbh & Co. Kg53%
Aseptico, Inc.43%
Berchtold Holding Gmbh21%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SircaChromophare F300Dr. VampazumaxEL3 LEDEL 10 LEDMINI-CCOMBI LAMP MINI3000CLIP LAMP MINI3000MINI-EEAR LIGHTn.a.Maquet RoliteLUCEA LED®PFLeo Minor

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

FDA product codes

CodeNameDevices
FSSLight, surgical, floor standing40
KZFDevice, Medical Examination, Ac Powered27
KZFDevice, medical examination, ac powered23
FSYLight, Surgical, Ceiling Mounted17
KYTLight, Examination, Medical, Battery Powered15
FSSLight, Surgical, Floor Standing15

GMDN & GCC registration

  • GMDN code 36843 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 26% · OTC 5%
  • 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 mobile examination/treatment room light products are registered in the US?

155 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mobile examination/treatment room light", from 17 companies. The largest labeler is Medical Illumination International Inc. with 22% of records.

Which FDA product codes apply?

FSS (Light, surgical, floor standing), KZF (Device, Medical Examination, Ac Powered), KZF (Device, medical examination, ac powered), FSY (Light, Surgical, Ceiling Mounted)

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.

How do I get quotes?

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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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