Consulting Wallah › Device Explorer › Ophthalmic › Ophthalmic surgical microscope
Device Explorer · FDA GUDID · GMDN 64676

Ophthalmic surgical microscope

An electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify structures within the eye or its surroundings, and/or provide slit-lamp functionality to delineate intraocular structures

US‑registered devices129in commercial distribution
Companies14labelers on GUDID
Single‑use6%of device records
Sterile6%labelled sterile
Prescription35%Rx‑only share
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Share of device records

Oculus Optikgeräte Gesellschaft Mit Beschränkter Haftung6651%
Alcon Laboratories, Inc.129%
Inami & Co., Ltd.97%
Leica Microsystems (Schweiz) Ag97%
Topcon Corporation75%
Carl Zeiss Meditec Ag65%
Haag-Streit Ag54%
Zumax Medical Co., Ltd43%

Top labelers

CompanyDevicesShare
Oculus Optikgeräte Gesellschaft Mit Beschränkter Haftung6651%
Alcon Laboratories, Inc.129%
Inami & Co., Ltd.97%
Leica Microsystems (Schweiz) Ag97%
Topcon Corporation75%
Carl Zeiss Meditec Ag65%
Haag-Streit Ag54%
Zumax Medical Co., Ltd43%
Shenzhen Certainn Technology Co., Ltd.32%
Munich Surgical Imaging Gmbh32%
Labotech Microscopes India Private Limited22%
Carl Zeiss Meditec (Suzhou) Co., Ltd.11%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OPMI LUMERA 300MOPTIMzumaxMediworksOPMI® LUMERA® 300TV RELAY LENS TL-6ATV RELAY LENS TL-7ABEAM SPLITTER MS-BS03-50/50OBLIQUE ILLUMINATOR MS-OI04TL-5AINAMIHeidelberg OPERASeeLumaCable CAN BIOM 6 for B&L SeeLumaCable Y BIOM 6 for Alcon LuxORRevaliaCable CTRL BIOM 6 for Leica Proveo 8 / 8x

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

FDA product codes

CodeNameDevices
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic113
HRMMICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC15
HOHSpectacle, Operating (Loupe), Ophthalmic8
FSOMICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY8
FSOMicroscope, Surgical, General & Plastic Surgery2
NFFDevice, Storage, Images, Ophthalmic1

GMDN & GCC registration

  • GMDN code 64676 · non‑implantable
  • Single‑use 6% · sterile 6% · Rx‑only 35% · 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

Length (Millimeter) · 1Depth (Millimeter) · 1Height (Millimeter) · 1

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

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

129 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic surgical microscope", from 14 companies. The largest labeler is Oculus Optikgeräte Gesellschaft Mit Beschränkter Haftung with 51% of records.

Which FDA product codes apply?

HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic), HRM (MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC), HOH (Spectacle, Operating (Loupe), Ophthalmic), FSO (MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY)

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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