Consulting Wallah › Device Explorer › Other devices › Vaginal speculum, reusable
Device Explorer · FDA GUDID · GMDN 35352

Vaginal speculum, reusable

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 consists of two long blades, joined at a handle at one end, that are

US‑registered devices3,551in commercial distribution
Companies49labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription70%Rx‑only share
ShareLinkedIn

Share of device records

Elmed Incorporated71220%
Avalign Technologies, Inc.2868%
Hayden Medical, Inc.2196%
Novo Surgical, Inc.1955%
Surgical Direct, Inc.1805%
Marina Medical Instruments, Inc.1705%
Sklar Corporation1625%
Medgyn Products, Inc.1605%

Top labelers

CompanyDevicesShare
Elmed Incorporated71220%
Avalign Technologies, Inc.2868%
Hayden Medical, Inc.2196%
Novo Surgical, Inc.1955%
Surgical Direct, Inc.1805%
Marina Medical Instruments, Inc.1705%
Sklar Corporation1625%
Medgyn Products, Inc.1605%
Medicon Eg. Chirurgiemechaniker-Genossenschaft1314%
Hnm Stainless, Llc.1193%
Aesculap Ag1123%
Surtex Instruments Ltd.1053%

Company = labeler of record on GUDID. 49 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SurtexHermann Medizintechnik GmbHAbdominal speculaMirror, Valve 23cm 20mmRZ Medizintechnik GmbHGimmiAESCULAPRESOURCEMediconVaginal Speculum - PedersonVaginal Speculum - Weisman Graves/Right side opeVaginal Speculum - Weisman GravesVaginal Speculum- Vu-MoreEndocervical speculumEndocervical SpeculumJackson Vaginal Retractor

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

FDA product codes

CodeNameDevices
HDFSpeculum, Vaginal, Metal1,679
HDFSPECULUM, VAGINAL, METAL1,415
HDLRETRACTOR, VAGINAL181
HDLRetractor, Vaginal146
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY105
GAFSpatula, Surgical, General & Plastic Surgery30

GMDN & GCC registration

  • GMDN code 35352 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 70% · 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) · 125Width (Millimeter) · 120Length (Centimeter) · 90Length (Inch) · 46Depth (Millimeter) · 29Width (Inch) · 21

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

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

3,551 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vaginal speculum, reusable", from 49 companies. The largest labeler is Elmed Incorporated with 20% of records.

Which FDA product codes apply?

HDF (Speculum, Vaginal, Metal), HDF (SPECULUM, VAGINAL, METAL), HDL (RETRACTOR, VAGINAL), HDL (Retractor, Vaginal)

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?

Add vaginal speculum, reusable to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Vaginal speculum, reusable

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying vaginal speculum, reusable for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →