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Device Explorer · FDA GUDID · GMDN 11267

Vaginal dilator

A firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., tr

US‑registered devices851in commercial distribution
Companies29labelers on GUDID
Single‑use22%of device records
Sterile0%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Elmed Incorporated18522%
Novo Surgical, Inc.16820%
Marina Medical Instruments, Inc.10913%
Medicon Eg. Chirurgiemechaniker-Genossenschaft739%
Rz-Medizintechnik Gmbh627%
Surgix Medical Llc476%
Aesculap Ag455%
Coopersurgical, Inc.182%

Top labelers

CompanyDevicesShare
Elmed Incorporated18522%
Novo Surgical, Inc.16820%
Marina Medical Instruments, Inc.10913%
Medicon Eg. Chirurgiemechaniker-Genossenschaft739%
Rz-Medizintechnik Gmbh627%
Surgix Medical Llc476%
Aesculap Ag455%
Coopersurgical, Inc.182%
Bioteque Taiwan Ltd.152%
Kls-Martin L.P.152%
Avalign Technologies, Inc.152%
Panpac Medical Corporation132%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REBLOOM GRS VAGINAL TRAINERSBiotequeNARZ Medizintechnik GmbHMediconAESCULAPVagiwell Dilators 5LSVagiwell Dilators 6 size 39-41/188mmVaginal Dilator 3er Set largeVaginal Dilator 3er Set smallVagiwell Dilator 5er Set PremiumVagiwell 0 size 10-11/112mmLANDANGERMilex Vaginal-Rectal dilatorMilex Vaginal-Rectal dilator setMilex Vaginal dilator set- Pediatric

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

FDA product codes

CodeNameDevices
HDQDilator, Cervical, Fixed Size392
HDQDILATOR, CERVICAL, FIXED SIZE279
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE62
HDXDilator, Vaginal54
FBXSound, Urethral, Metal Or Plastic35
KXPStent, Vaginal13

GMDN & GCC registration

  • GMDN code 11267 · non‑implantable
  • Single‑use 22% · sterile 0% · Rx‑only 83% · OTC 2%
  • 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) · 59Length (Inch) · 44Length (Millimeter) · 18Catheter Gauge (French) · 14Width (Centimeter) · 8Width (Millimeter) · 2

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

How many vaginal dilator products are registered in the US?

851 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vaginal dilator", from 29 companies. The largest labeler is Elmed Incorporated with 22% of records.

Which FDA product codes apply?

HDQ (Dilator, Cervical, Fixed Size), HDQ (DILATOR, CERVICAL, FIXED SIZE), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), HDX (Dilator, 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?

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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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