Device Explorer · FDA GUDID · GMDN 62703

Microkeratome

An electrically-powered ophthalmic surgical instrument intended to be used to create a corneal pocket for the insertion of a corneal implant or to create a flap to prepare the cornea for laser vision correction. It typically consists of a suction ring, an appl

US‑registered devices55in commercial distribution
Companies2labelers on GUDID
Single‑use36%of device records
Sterile35%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Moria Sa4276%
Med Logics Inc1324%

Top labelers

CompanyDevicesShare
Moria Sa4276%
Med Logics Inc1324%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MORIAVacuum Handle, ML7Ring, ML7, 10.0mmRing, ML7, 9.5mmRing, ML7, 9.0mmRing, ML7, 8.5mmRing, ML7, 8.0mmHead, ML7, 130 MicronHead, ML7, 100 MicronSterilization Tray, ML7Handpiece, ML7Footswitch, ML7ML7 MicrokeratomeWrench, Helical Drive, ML7

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

FDA product codes

CodeNameDevices
HNOKeratome, Ac-Powered30
HMYKeratome, Battery-Powered26

GMDN & GCC registration

  • GMDN code 62703 · non‑implantable
  • Single‑use 36% · sterile 35% · Rx‑only 100% · 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 microkeratome products are registered in the US?

55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Microkeratome", from 2 companies. The largest labeler is Moria Sa with 76% of records.

Which FDA product codes apply?

HNO (Keratome, Ac-Powered), HMY (Keratome, Battery-Powered)

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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