Device Explorer · FDA GUDID · GMDN 10960

Colposcope

An electrically-powered instrument intended to be used for the visual examination and treatment of the female genitalia. It is placed directly at the opening of the vagina which is held open with an inserted speculum during colposcopy. The instrument has a lig

US‑registered devices162in commercial distribution
Companies26labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription41%Rx‑only share
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Share of device records

Ecleris2717%
Coopersurgical, Inc.2515%
Gynex Corporation1811%
Henry Schein, Inc.159%
Aspen Surgical Products, Inc.96%
Edan Instruments, Inc.74%
United Products & Instruments74%
Medgyn Products, Inc.74%

Top labelers

CompanyDevicesShare
Ecleris2717%
Coopersurgical, Inc.2515%
Gynex Corporation1811%
Henry Schein, Inc.159%
Aspen Surgical Products, Inc.96%
Edan Instruments, Inc.74%
United Products & Instruments74%
Medgyn Products, Inc.74%
Xuzhou Kernel Medical Equipment Co., Ltd.64%
Dysis Medical Limited64%
Mckesson Medical-Surgical Inc.53%
Optomic España Sa53%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GyniusLiger MedicalALLTIONzumaxUHD series Video ColposcopeVideo ColposcopeKernelDYSIS ViewDYSIS Ultra 2.0DYSIS UltraDYSIS v3 Digital CoploscopeDYSIS v3 Digital ColposcopeATMOSKSK 150 FCLEISEGANG OptiK® Model 2 ColposcopeColpoStar™ 1H Colposcope

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

FDA product codes

CodeNameDevices
HEXColposcope (And Colpomicroscope)137
PTZColposcope (And Colpomicroscope), Exempt24
HEXCOLPOSCOPE (AND COLPOMICROSCOPE)23
HEXColposcope (and colpomicroscope)3
DRCTrocar2
EPTMicroscope, Surgical1

GMDN & GCC registration

  • GMDN code 10960 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 41% · 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

No structured size data on the register.

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

No closely related category with 50+ devices.

How many colposcope products are registered in the US?

162 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Colposcope", from 26 companies. The largest labeler is Ecleris with 17% of records.

Which FDA product codes apply?

HEX (Colposcope (And Colpomicroscope)), PTZ (Colposcope (And Colpomicroscope), Exempt), HEX (COLPOSCOPE (AND COLPOMICROSCOPE)), HEX (Colposcope (and colpomicroscope))

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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