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Device Explorer · FDA GUDID · GMDN 64958

Eye splash shield, reusable

A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or

US‑registered devices162in commercial distribution
Companies9labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Hager Worldwide, Inc.7546%
Maxill, Inc.3421%
Eye Ojo Corp.2817%
Taizhou Yuanming Glasses Co., Ltd106%
Univet Srl64%
Gf Health Products, Inc.42%
Reliance Orthodontic Products Inc21%
Jmu Dental, Inc21%

Top labelers

CompanyDevicesShare
Hager Worldwide, Inc.7546%
Maxill, Inc.3421%
Eye Ojo Corp.2817%
Taizhou Yuanming Glasses Co., Ltd106%
Univet Srl64%
Gf Health Products, Inc.42%
Reliance Orthodontic Products Inc21%
Jmu Dental, Inc21%
Mdhc Life Technologies (Kunshan) Co., Ltd.11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MDHCREC SAFETY GOGGLESSafety glassesmaxill Frames Eyewear Adultmaxill Frames Eyewear Kidsmaxill Frames EyewearSAFETY GLASSESJMUHyper ToughOZARK TRAILUVEX GOGGLE CASE (BLACK W/ZIPPER) EYEWEAR STORAGUVEX STEALTH GOGGLES (GRAY FRAME/CLEAR LENS) EYEUVEX STEALTH OTG GOGGLE (NAVY BODY/CLEAR LENS) EClip-on Loupe10 Diopter(#710)Clip-on Loupe 7 Diopter (#717)Wire Clip-On Loupe (+5)

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

FDA product codes

CodeNameDevices
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea79
HOYShield, eye, ophthalmic (including sunlamp protective eyewea72
LYUAccessory, Surgical Apparel6
HQZFrame, Spectacle5
KPYShield, Protective, Personnel1

GMDN & GCC registration

  • GMDN code 64958 · non‑implantable
  • Single‑use 1% · 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 eye splash shield, reusable products are registered in the US?

162 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Eye splash shield, reusable", from 9 companies. The largest labeler is Hager Worldwide, Inc. with 46% of records.

Which FDA product codes apply?

HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea), HOY (Shield, eye, ophthalmic (including sunlamp protective eyewea), LYU (Accessory, Surgical Apparel), HQZ (Frame, Spectacle)

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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