Consulting Wallah › Device Explorer › Other devices › Vaginal speculum, single-use
Device Explorer · FDA GUDID · GMDN 37468

Vaginal speculum, single-use

A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end,

US‑registered devices382in commercial distribution
Companies48labelers on GUDID
Single‑use95%of device records
Sterile39%labelled sterile
Prescription60%Rx‑only share
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Share of device records

Sklar Corporation308%
Centurion Medical Products Corporation277%
Robinson Healthcare Limited267%
Welch Allyn, Inc.226%
Kolplast C I205%
North Eos Industries Inc.195%
Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.185%
Bioseal185%

Top labelers

CompanyDevicesShare
Sklar Corporation308%
Centurion Medical Products Corporation277%
Robinson Healthcare Limited267%
Welch Allyn, Inc.226%
Kolplast C I205%
North Eos Industries Inc.195%
Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.185%
Bioseal185%
Dtr Medical Limited174%
Coopersurgical, Inc.164%
Prestige Ameritech, Ltd.154%
Obp Corporation154%

Company = labeler of record on GUDID. 48 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

V-CaliperSHENGBOIOBGongdongMeridian VPSSPECULUXCusco Specula Metal Small XXLongCusco Specula Metal Medium LongCusco Specula Metal BroadCusco Specula Metal Large Extra LongCusco Specula Metal Large LongCusco Specula Insulated with Smoke Tube BroadCusco Specula Insulated with Smoke Tube Large ExCusco Specula Insulated with Smoke Tube Large LoCusco Specula Metal LargeCusco Specula Metal Medium

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

FDA product codes

CodeNameDevices
HIBSpeculum, Vaginal, Nonmetal235
HDFSPECULUM, VAGINAL, METAL77
HIBSpeculum, vaginal, nonmetal73
HDFSpeculum, Vaginal, Metal21
HICSpeculum, Vaginal, Nonmetal, Fiberoptic12
LKFCannula, manipulator/injector, uterine1

GMDN & GCC registration

  • GMDN code 37468 · non‑implantable
  • Single‑use 95% · sterile 39% · Rx‑only 60% · 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 (Centimeter) · 3Length (Inch) · 1

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

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

382 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vaginal speculum, single-use", from 48 companies. The largest labeler is Sklar Corporation with 8% of records.

Which FDA product codes apply?

HIB (Speculum, Vaginal, Nonmetal), HDF (SPECULUM, VAGINAL, METAL), HIB (Speculum, vaginal, nonmetal), HDF (Speculum, Vaginal, Metal)

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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