Device Explorer · FDA GUDID · GMDN 46807

Head-worn lamp

An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb,

US‑registered devices404in commercial distribution
Companies35labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription19%Rx‑only share
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Share of device records

Riverpoint Medical, Llc8922%
Enova Illumination, Inc.7418%
Zumax Medical Co., Ltd4210%
Black & Black Surgical, Inc.4210%
Quality Aspirators, Inc.318%
Power Dental U.S.A. Inc.215%
Taiyo Corporation154%
Medical Illumination International Inc.123%

Top labelers

CompanyDevicesShare
Riverpoint Medical, Llc8922%
Enova Illumination, Inc.7418%
Zumax Medical Co., Ltd4210%
Black & Black Surgical, Inc.4210%
Quality Aspirators, Inc.318%
Power Dental U.S.A. Inc.215%
Taiyo Corporation154%
Medical Illumination International Inc.123%
Long Island Tech102%
Heine Optotechnik Gmbh & Co. Kg72%
Univet Loupes Spa61%
Elmed Incorporated51%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

zumaxEighteethATMOSevonosMICROLIGHT 2LOUPELIGHT 2POLARISATION FILTER P2 LOUPELIGHTPOLARISATION FILTER P2 ML 4ML4 LEDYELLOW FILTER ML4 LEDYELLOW FILTER LOUPELIGHTclar N 55, LED 6 V, incl. lithium batteriesri-focus® LED, 6 V, incl. rechargeableri-focus® LED, 6 V, incl. lithium batteriesPower Dental USAN/A

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

FDA product codes

CodeNameDevices
HPPHeadlamp, Operating, Battery-Operated236
EBALight, Surgical Headlight51
EBALIGHT, SURGICAL HEADLIGHT38
KYTLIGHT, EXAMINATION, MEDICAL, BATTERY POWERED29
HPPHeadlamp, operating, battery-operated28
KYTLight, Examination, Medical, Battery Powered19

GMDN & GCC registration

  • GMDN code 46807 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 19% · 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

No structured size data on the register.

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

No closely related category with 50+ devices.

How many head-worn lamp products are registered in the US?

404 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Head-worn lamp", from 35 companies. The largest labeler is Riverpoint Medical, Llc with 22% of records.

Which FDA product codes apply?

HPP (Headlamp, Operating, Battery-Operated), EBA (Light, Surgical Headlight), EBA (LIGHT, SURGICAL HEADLIGHT), KYT (LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED)

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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