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Device Explorer · FDA GUDID · GMDN 32816

Spectacle frame

An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by inc

US‑registered devices29,596in commercial distribution
Companies26labelers on GUDID
Single‑use12%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Etnia Barcelona, Llc.6,18521%
Westgroupe Optical Inc5,37618%
Bbig B.V.3,66412%
Masunaga Optical Mfg.Co.,Ltd.3,03410%
Bellinger A/S2,0087%
Mpg Gmbh1,9287%
Eyevan Inc.1,7576%
Mcgee Group, Inc., The1,3535%

Top labelers

CompanyDevicesShare
Etnia Barcelona, Llc.6,18521%
Westgroupe Optical Inc5,37618%
Bbig B.V.3,66412%
Masunaga Optical Mfg.Co.,Ltd.3,03410%
Bellinger A/S2,0087%
Mpg Gmbh1,9287%
Eyevan Inc.1,7576%
Mcgee Group, Inc., The1,3535%
Tura Inc.8453%
Eyewear By Roi, Limited6622%
Incite International Inc5782%
Fielmann Group Ag5352%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BLACEntourage of 7BellingerBlacGreat Dane SpectaclesEYEVAN7285E5 eyevanEYEVAN HISTORIC COLLECTIONEYEVAN10eyevanMASUNAGA since 1905MASUNAGA MOCKOOKIKazuo KawasakiKEN OKUYAMAFielmann

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

FDA product codes

CodeNameDevices
HQZFrame, Spectacle21,200
HQZFrame, spectacle6,365
HQRApparatus, cautery, radiofrequency, ac-powered1,353
HQYSunglasses (Non-Prescription Including Photosensitive)1,197
HQYSunglasses (non-prescription including photosensitive)179
HYQIron Chloride-Weigert1

GMDN & GCC registration

  • GMDN code 32816 · non‑implantable
  • Single‑use 12% · 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

Width (Millimeter) · 742Width (Micrometer) · 1

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

No closely related category with 50+ devices.

How many spectacle frame products are registered in the US?

29,596 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spectacle frame", from 26 companies. The largest labeler is Etnia Barcelona, Llc. with 21% of records.

Which FDA product codes apply?

HQZ (Frame, Spectacle), HQZ (Frame, spectacle), HQR (Apparatus, cautery, radiofrequency, ac-powered), HQY (Sunglasses (Non-Prescription Including Photosensitive))

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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