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Device Explorer · FDA GUDID · GMDN 32037

General-purpose light source

A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this

US‑registered devices409in commercial distribution
Companies32labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription50%Rx‑only share
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Share of device records

Metrex Research, Llc21352%
Integra Lifesciences (Ireland) Limited4411%
Integra Lifesciences Production Corporation236%
Ecleris164%
Quality Aspirators, Inc.133%
Br Surgical, Llc123%
Sunoptic Technologies Llc123%
Medical Illumination International Inc.102%

Top labelers

CompanyDevicesShare
Metrex Research, Llc21352%
Integra Lifesciences (Ireland) Limited4411%
Integra Lifesciences Production Corporation236%
Ecleris164%
Quality Aspirators, Inc.133%
Br Surgical, Llc123%
Sunoptic Technologies Llc123%
Medical Illumination International Inc.102%
Teleflex Incorporated92%
Gf Health Products, Inc.72%
Pentax Of America, Inc.61%
Sontec Instruments, Inc.51%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/AInfa Lite AC100-240VRZ Medizintechnik GmbHAESCULAPI-Tek I-150 LED Light SourceNano Freedom HeadlightNova 300BeamerBR Surgical, LLCNICO Myriad-LXStrykerHigh CRI LED Light SourceSpark™ TruColor™MSILight, Headband, SurgicalAED

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

FDA product codes

CodeNameDevices
EBALight, Surgical Headlight122
EBALIGHT, SURGICAL HEADLIGHT94
FSTLIGHT, SURGICAL, FIBEROPTIC35
FCWLight source, fiberoptic, routine34
FSRLight, headband, surgical32
FCWLight Source, Fiberoptic, Routine15

GMDN & GCC registration

  • GMDN code 32037 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 50% · 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 (Inch) · 2Height (Inch) · 2Length (Inch) · 2Depth (Centimeter) · 1Width (Centimeter) · 1Depth (Inch) · 1

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

How many general-purpose light source products are registered in the US?

409 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-purpose light source", from 32 companies. The largest labeler is Metrex Research, Llc with 52% of records.

Which FDA product codes apply?

EBA (Light, Surgical Headlight), EBA (LIGHT, SURGICAL HEADLIGHT), FST (LIGHT, SURGICAL, FIBEROPTIC), FCW (Light source, fiberoptic, routine)

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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