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Device Explorer · FDA GUDID · GMDN 36628

Rigid optical hysteroscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user throug

US‑registered devices151in commercial distribution
Companies20labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription75%Rx‑only share
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Share of device records

National Advanced Endoscopy Devices, Inc.2114%
Hologic, Inc.2013%
Sopro-Comeg Gmbh1812%
Karl Storz Gmbh & Co. Kg1711%
Covidien Lp1510%
Avalign Technologies, Inc.107%
American Medical Endoscopy, Inc.85%
Stryker Corporation64%

Top labelers

CompanyDevicesShare
National Advanced Endoscopy Devices, Inc.2114%
Hologic, Inc.2013%
Sopro-Comeg Gmbh1812%
Karl Storz Gmbh & Co. Kg1711%
Covidien Lp1510%
Avalign Technologies, Inc.107%
American Medical Endoscopy, Inc.85%
Stryker Corporation64%
Br Surgical, Llc64%
Hermann Medizintechnik Gmbh53%
Smith & Nephew, Inc.53%
Medivision, Inc.43%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAIdeal EyesHermann Medizintechnik GmbHHysteroscopePANOVIEW PLUSGimmiHOPKINSn.a.TROPHYscopeB.I.O.H.HAMOU / HOPKINSOlympusHYST/DSSH/Ø5,5/AK/5CH/30°/2FH/OL/WE/COVIHYST/USH/1DBH/Ø2,9/302/30/TL/WE/COVIDIENHYST 2,9/30/300 AK HD COVIDIENTRUCLEARTM Operative Hysteroscope 5.0

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

FDA product codes

CodeNameDevices
HIHHYSTEROSCOPE (AND ACCESSORIES)115
HIHHysteroscope (And Accessories)15
FAJCystoscope and accessories, flexible/rigid13
FAJCystoscope And Accessories, Flexible/Rigid12
NWWHysteroscope Accessories8
NWWHysteroscope accessories6

GMDN & GCC registration

  • GMDN code 36628 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 75% · 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) · 23Angle (degree) · 3Length (Millimeter) · 3Height (Millimeter) · 1Width (Millimeter) · 1

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

How many rigid optical hysteroscope products are registered in the US?

151 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rigid optical hysteroscope", from 20 companies. The largest labeler is National Advanced Endoscopy Devices, Inc. with 14% of records.

Which FDA product codes apply?

HIH (HYSTEROSCOPE (AND ACCESSORIES)), HIH (Hysteroscope (And Accessories)), FAJ (Cystoscope and accessories, flexible/rigid), FAJ (Cystoscope And Accessories, Flexible/Rigid)

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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