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Device Explorer · FDA GUDID · GMDN 35349

Eyelid speculum, reusable

A self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic 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 devices2,042in commercial distribution
Companies46labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Med Saver, Inc.22311%
Katena Products, Inc.21110%
Ambler Surgical Corp.20010%
Sontec Instruments, Inc.1527%
Avalign Technologies, Inc.1186%
Walcott Rx Product Inc1156%
Aurora Surgical, Llc945%
Sklar Corporation824%

Top labelers

CompanyDevicesShare
Med Saver, Inc.22311%
Katena Products, Inc.21110%
Ambler Surgical Corp.20010%
Sontec Instruments, Inc.1527%
Avalign Technologies, Inc.1186%
Walcott Rx Product Inc1156%
Aurora Surgical, Llc945%
Sklar Corporation824%
Daud Jee Mfg. Co593%
Bausch & Lomb Incorporated583%
Surtex Instruments Ltd.543%
Krishna Imports Inc512%

Company = labeler of record on GUDID. 46 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SurtexDuckworth & KentMod. Krumeich Eye SpeculumLieberman Eye SpeculumKratz-Barraquer Wire SpeculumMellinger Eye SpeculumCastroviejo SpeculumN.A.GimmiAESCULAPMediconMORIABOSS InstrumentsSymmetry AlfonsoSymmetry SauerSymmetry Kratz-Barraquer

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

FDA product codes

CodeNameDevices
HNCSpecula, ophthalmic1,317
HNCSpecula, Ophthalmic519
HNIRetractor, ophthalmic119
HNIRetractor, Ophthalmic48
HODClamp, Eyelid, Ophthalmic17
MDMInstrument, Manual, Surgical, General Use14

GMDN & GCC registration

  • GMDN code 35349 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 64% · 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

Length (Millimeter) · 54Length (Inch) · 52Width (Millimeter) · 35Depth (Millimeter) · 1Length (Centimeter) · 1

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

How many eyelid speculum, reusable products are registered in the US?

2,042 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Eyelid speculum, reusable", from 46 companies. The largest labeler is Med Saver, Inc. with 11% of records.

Which FDA product codes apply?

HNC (Specula, ophthalmic), HNC (Specula, Ophthalmic), HNI (Retractor, ophthalmic), 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.

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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