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Device Explorer · FDA GUDID · GMDN 35191

General-purpose surgical microscope

A general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light

US‑registered devices664in commercial distribution
Companies24labelers on GUDID
Single‑use3%of device records
Sterile3%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Global Surgical Corporation25438%
Zumax Medical Co., Ltd13721%
Ecleris6410%
Volk Optical Inc.599%
Alltion (Guangxi) Instrument Co., Ltd.254%
Leica Microsystems (Schweiz) Ag233%
Viseon, Inc.223%
Carl Zeiss Meditec Ag173%

Top labelers

CompanyDevicesShare
Global Surgical Corporation25438%
Zumax Medical Co., Ltd13721%
Ecleris6410%
Volk Optical Inc.599%
Alltion (Guangxi) Instrument Co., Ltd.254%
Leica Microsystems (Schweiz) Ag233%
Viseon, Inc.223%
Carl Zeiss Meditec Ag173%
Labotech Microscopes India Private Limited122%
Mitaka Kohki Co., Ltd.81%
Carl Zeiss Meditec (Suzhou) Co., Ltd.61%
Seiler Instrument And Manufacturing Company, Incorporated61%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EXTARO 300Medical MicroscopeALLTIONzumaxMediWorksMediworksEighteethEXTARO® 300ORBEYE SURGICAL MICROSCOPESurgical Microscope MM51/SOH4K3D Video Microscope HawkSightSurgical Microscope MM90/SOHSurgical Microscope MM90/SS1Surgical Microscope MM80/SS1Surgical Microscope MM80/SOHSurgical Microscope MM80/YOH

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

FDA product codes

CodeNameDevices
EPTMicroscope, Surgical375
FSOMicroscope, Surgical, General & Plastic Surgery252
EPTMICROSCOPE, SURGICAL26
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic10
FSOMICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY5
HRMMICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC3

GMDN & GCC registration

  • GMDN code 35191 · non‑implantable
  • Single‑use 3% · sterile 3% · Rx‑only 49% · 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 general-purpose surgical microscope products are registered in the US?

664 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-purpose surgical microscope", from 24 companies. The largest labeler is Global Surgical Corporation with 38% of records.

Which FDA product codes apply?

EPT (Microscope, Surgical), FSO (Microscope, Surgical, General & Plastic Surgery), EPT (MICROSCOPE, SURGICAL), 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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