Consulting Wallah › Device Explorer › Other devices › Eyelid speculum, single-use
Device Explorer · FDA GUDID · GMDN 46959

Eyelid speculum, single-use

A self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expande

US‑registered devices136in commercial distribution
Companies17labelers on GUDID
Single‑use96%of device records
Sterile76%labelled sterile
Prescription36%Rx‑only share
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Share of device records

Sklar Corporation4130%
Blink Medical Limited2418%
Psi/Eye-Ko, Inc.1612%
Hasa Optix86%
Moria Sa86%
Krishna Imports Inc86%
Beaver-Visitec International, Inc.64%
Neotech Products Llc64%

Top labelers

CompanyDevicesShare
Sklar Corporation4130%
Blink Medical Limited2418%
Psi/Eye-Ko, Inc.1612%
Hasa Optix86%
Moria Sa86%
Krishna Imports Inc86%
Beaver-Visitec International, Inc.64%
Neotech Products Llc64%
Katena Products, Inc.43%
Deroyal Industries, Inc.32%
Dr.Frigz International(Pvt)Ltd,32%
Dtr Medical Limited21%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sterile, Single Use, Speculum Adjustable Fine FuSterile, Single Use, Lindstrom-Chu Aspirating SpSterile,Single Use,Adjustable Speculum,Speculum,Sterile, Single Use, Lieberman Adjustable SpeculSterile, Single Use, Wire Speculum, 14mm Open BlSterile, Single Use, Kratz Barraquer Wire SpeculSterile, Single Use, Speculum Adjustable Full RSterile, Single Use, Speculum Lieberman Fine, OpSpeculum Solid BladeSpeculum Barraquer Solid Plastic BladeSpeculum Kratz-Barraquer Curved Angled TemporalSpeculum Leibinger Solid BladeSpeculum Neo-Natal Strong Spring Angled TemporalSpeculum Neo-Natal Angled TemporalSpeculum ClarkesSpeculum Cook Eye

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

FDA product codes

CodeNameDevices
HNCSpecula, ophthalmic64
HNCSpecula, Ophthalmic60
FXGSpecula Accessories6
HNIRetractor, Ophthalmic3
HNDSpatula, ophthalmic1
EPYSpeculum, Ent1

GMDN & GCC registration

  • GMDN code 46959 · non‑implantable
  • Single‑use 96% · sterile 76% · Rx‑only 36% · OTC 1%
  • 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) · 2Length (Centimeter) · 1

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

How many eyelid speculum, single-use products are registered in the US?

136 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Eyelid speculum, single-use", from 17 companies. The largest labeler is Sklar Corporation with 30% of records.

Which FDA product codes apply?

HNC (Specula, ophthalmic), HNC (Specula, Ophthalmic), FXG (Specula Accessories), HNI (Retractor, 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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