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Device Explorer · FDA GUDID · GMDN 12538

ENT surgical microscope

A light (optical) magnification instrument designed to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing. It typically consists of a stereo micros

US‑registered devices207in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Jedmed Instrument Company14470%
Seiler Instrument And Manufacturing Company, Incorporated4823%
Br Surgical, Llc84%
Atmos Medizintechnik Gmbh & Co. Kg42%
Optomic España Sa31%

Top labelers

CompanyDevicesShare
Jedmed Instrument Company14470%
Seiler Instrument And Manufacturing Company, Incorporated4823%
Br Surgical, Llc84%
Atmos Medizintechnik Gmbh & Co. Kg42%
Optomic España Sa31%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ATMOSBR Surgical, LLCSEILER MEDICAL DIVISIONJEDMEDOptomic

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

FDA product codes

CodeNameDevices
EPTMicroscope, Surgical200
FSOMicroscope, Surgical, General & Plastic Surgery4
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic3

GMDN & GCC registration

  • GMDN code 12538 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 0% · 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

No structured size data on the register.

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

How many ent surgical microscope products are registered in the US?

207 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "ENT surgical microscope", from 5 companies. The largest labeler is Jedmed Instrument Company with 70% of records.

Which FDA product codes apply?

EPT (Microscope, Surgical), FSO (Microscope, Surgical, General & Plastic Surgery), HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic)

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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