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Device Explorer · FDA GUDID · GMDN 47987

Fixed-diameter cervical dilator, single-use

A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have o

US‑registered devices58in commercial distribution
Companies10labelers on GUDID
Single‑use100%of device records
Sterile86%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Centurion Medical Products Corporation1221%
Gynex Corporation1017%
Bioteque Taiwan Ltd.916%
Coopersurgical, Inc.712%
Robinson Healthcare Limited610%
North Eos Industries Inc.59%
Best Medical International, Inc.35%
Bioseal35%

Top labelers

CompanyDevicesShare
Centurion Medical Products Corporation1221%
Gynex Corporation1017%
Bioteque Taiwan Ltd.916%
Coopersurgical, Inc.712%
Robinson Healthcare Limited610%
North Eos Industries Inc.59%
Best Medical International, Inc.35%
Bioseal35%
Integra Lifesciences Production Corporation23%
Womancare Global Trading, Inc.12%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

InstrapacLTL MedicalBiotequeEOSOs FinderDilator/ Sound SetCanal DilatorOS LocatorUterine Explora Curette - Model IIUterine Explora Curette - Model IMonarch Medical ProductsU.A. Medical ProductsWomanCare Global Miscarriage Management KitBest Medical InternationalBioteque America, Inc.Centurion

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 Size30
HDQDILATOR, CERVICAL, FIXED SIZE11
KNAINSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC6
HHKCurette, Suction, Endometrial (And Accessories)3
IWJSystem, Applicator, Radionuclide, Manual3
KDCINSTRUMENT, SURGICAL, DISPOSABLE3

GMDN & GCC registration

  • GMDN code 47987 · non‑implantable
  • Single‑use 100% · sterile 86% · Rx‑only 71% · 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

Outer Diameter (Millimeter) · 3

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

How many fixed-diameter cervical dilator, single-use products are registered in the US?

58 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fixed-diameter cervical dilator, single-use", from 10 companies. The largest labeler is Centurion Medical Products Corporation with 21% of records.

Which FDA product codes apply?

HDQ (Dilator, Cervical, Fixed Size), HDQ (DILATOR, CERVICAL, FIXED SIZE), KNA (INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC), HHK (Curette, Suction, Endometrial (And Accessories))

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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