Device Explorer · FDA GUDID · GMDN 44929

Otoscope, endoscopic

An endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic b

US‑registered devices89in commercial distribution
Companies18labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription72%Rx‑only share
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Share of device records

Karl Storz Gmbh & Co. Kg1921%
Happersberger Otopront Gmbh1112%
Gyrus Acmi, Llc910%
Ecleris910%
Optomic España Sa78%
Schölly Fiberoptic Gmbh56%
Henke-Sass, Wolf Gmbh56%
Sklar Corporation56%

Top labelers

CompanyDevicesShare
Karl Storz Gmbh & Co. Kg1921%
Happersberger Otopront Gmbh1112%
Gyrus Acmi, Llc910%
Ecleris910%
Optomic España Sa78%
Schölly Fiberoptic Gmbh56%
Henke-Sass, Wolf Gmbh56%
Sklar Corporation56%
Grace Medical, Inc.44%
National Advanced Endoscopy Devices, Inc.33%
Photonicare, Inc.22%
Elmed Incorporated22%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OTOPRONTPrimeSightn.a.HOPKINSN/AbebirdOtoSight Middle Ear Scope with BatteryOtoSight Middle Ear ScopeAEDEndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG.EndoEar™ ENDOSCOPE, 3MM X 150MM, 45 DEG.EndoEar™ ENDOSCOPE, 3MM X 150MM, 30 DEG.EndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG.ELMEDOTOVIEWMedRx

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

FDA product codes

CodeNameDevices
ERAOtoscope44
ERAOTOSCOPE18
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)10
EWASET, AUDIOMETER CALIBRATION10
EOBNasopharyngoscope (Flexible Or Rigid)8
EPYSPECULUM, ENT5

GMDN & GCC registration

  • GMDN code 44929 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 72% · 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) · 6Length (Millimeter) · 1Angle (degree) · 1

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No closely related category with 50+ devices.

How many otoscope, endoscopic products are registered in the US?

89 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Otoscope, endoscopic", from 18 companies. The largest labeler is Karl Storz Gmbh & Co. Kg with 21% of records.

Which FDA product codes apply?

ERA (Otoscope), ERA (OTOSCOPE), EOB (NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)), EWA (SET, AUDIOMETER CALIBRATION)

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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