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Device Explorer · FDA GUDID · GMDN 12282

Operating room light

A device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an indiv

US‑registered devices3,009in commercial distribution
Companies33labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Maquet Sas1,70257%
Amico Clinical Solutions Corp65922%
Steris Corporation2669%
S.I.M.E.O.N. Medical Gmbh & Co. Kg1575%
Medical Illumination International Inc.602%
Ls Enterprises, Inc.331%
Aadco Medical, Inc.161%
Shandong Deman Medical Equipment Group Co., Ltd.150%

Top labelers

CompanyDevicesShare
Maquet Sas1,70257%
Amico Clinical Solutions Corp65922%
Steris Corporation2669%
S.I.M.E.O.N. Medical Gmbh & Co. Kg1575%
Medical Illumination International Inc.602%
Ls Enterprises, Inc.331%
Aadco Medical, Inc.161%
Shandong Deman Medical Equipment Group Co., Ltd.150%
Shandong Lewin Medical Equipment Co., Ltd.140%
Baxter Medical Systems Gmbh + Co. Kg110%
Hayden Medical, Inc.90%
Acem Spa90%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MaisilideLEWINSAIKANGKENEXLight cable with iris, for head-lightDM MS Sim.LED ExL wSBMS Sim.LED OpL USMS Sim.LED OpL wDBMS Sim.LED OpL wSBDM MS Sim.LED ExL DESim.LED 8000 MC 9p LC Touch Adr. 2Sim.LED 8000 MC 5p LC Touch Adr. 2Sim.LED 8000 MC 3p LC Touch Adr. 2Sim.LED 8000 MC 9p LC Adr. 2Sim.LED 8000 MC 5p LC Adr. 2Sim.LED 8000 MC 3p LC Adr. 2

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

FDA product codes

CodeNameDevices
FTDLamp, surgical1,977
FSYLight, surgical, ceiling mounted1,792
FSYLight, Surgical, Ceiling Mounted910
FTDLamp, Surgical136
FTALight, Surgical, Accessories72
EAZLight, Operating, Dental35

GMDN & GCC registration

  • GMDN code 12282 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 1% · OTC 8%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 1

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

How many operating room light products are registered in the US?

3,009 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Operating room light", from 33 companies. The largest labeler is Maquet Sas with 57% of records.

Which FDA product codes apply?

FTD (Lamp, surgical), FSY (Light, surgical, ceiling mounted), FSY (Light, Surgical, Ceiling Mounted), FTD (Lamp, Surgical)

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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