Consulting Wallah › Device Explorer › Ophthalmic › Vision corrective trial lens
Device Explorer · FDA GUDID · GMDN 34653

Vision corrective trial lens

A non-patient-contact ophthalmic trial lens, or set of trial lenses of various dioptric powers, intended for vision testing to determine the required refraction for vision correction. This device may be used in conjunction with a phoropter (not included).

US‑registered devices181in commercial distribution
Companies2labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Bernell17999%
Ama Optics, Inc.21%

Top labelers

CompanyDevicesShare
Bernell17999%
Ama Optics, Inc.21%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BernellAMA Optics Panoramic PinholeAMA Optics Lens Holder

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

FDA product codes

CodeNameDevices
HPCSet, Lens, Trial, Ophthalmic175
HMHRack, Skiascopic5
HPBClip, Lens, Trial, Ophthalmic1

GMDN & GCC registration

  • GMDN code 34653 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 0% · OTC 99%
  • 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 vision corrective trial lens products are registered in the US?

181 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vision corrective trial lens", from 2 companies. The largest labeler is Bernell with 99% of records.

Which FDA product codes apply?

HPC (Set, Lens, Trial, Ophthalmic), HMH (Rack, Skiascopic), HPB (Clip, Lens, Trial, Ophthalmic)

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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