Consulting Wallah › Device Explorer › Ophthalmic › Ophthalmic conformer
Device Explorer · FDA GUDID · GMDN 16065

Ophthalmic conformer

An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surge

US‑registered devices95in commercial distribution
Companies19labelers on GUDID
Single‑use97%of device records
Sterile55%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Stryker Leibinger Gmbh & Co. Kg2425%
Integrated Orbital Implants Inc1213%
Gulden Ophthalmics Inc.1213%
Med Saver, Inc.99%
Oculo-Plastik Inc99%
Jardon Eye Prosthetics, Inc.55%
Fci S A S Fci 20 2244%
Biotissue Holdings Inc.44%

Top labelers

CompanyDevicesShare
Stryker Leibinger Gmbh & Co. Kg2425%
Integrated Orbital Implants Inc1213%
Gulden Ophthalmics Inc.1213%
Med Saver, Inc.99%
Oculo-Plastik Inc99%
Jardon Eye Prosthetics, Inc.55%
Fci S A S Fci 20 2244%
Biotissue Holdings Inc.44%
Ambler Surgical Corp.44%
Katena Products, Inc.33%
Dallas Eye Prosthetics11%
Soper Brothers, Incorporated11%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MEDPORNAOphthalmic conformerSILICONE CONFORMER (FLEXIBLE)Dallas Eye ProstheticsPROKERA®Silicone ConformerLucite ConformerBio-Eye®UNIVERSAL CONFORMER LARGEUNIVERSAL CONFORMER MEDIUMUNIVERSAL CONFORMER SMALLMSI Precision Specialty InstrumentsSoper Brothers CustomOphthalmic ConformerAmbler Surgical

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

FDA product codes

CodeNameDevices
HQNConformer, Ophthalmic82
HQNCONFORMER, OPHTHALMIC28
HPZImplant, Eye Sphere9
HOYShield, eye, ophthalmic (including sunlamp protective eyewea9
NQBConformer, Ophthalmic, Biological Tissue4
MTZWrap, Implant, Orbital4

GMDN & GCC registration

  • GMDN code 16065 · non‑implantable
  • Single‑use 97% · sterile 55% · Rx‑only 81% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 60Length (Millimeter) · 44Depth (Millimeter) · 35Height (Millimeter) · 18Length (Inch) · 12Width (Inch) · 12

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

How many ophthalmic conformer products are registered in the US?

95 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic conformer", from 19 companies. The largest labeler is Stryker Leibinger Gmbh & Co. Kg with 25% of records.

Which FDA product codes apply?

HQN (Conformer, Ophthalmic), HQN (CONFORMER, OPHTHALMIC), HPZ (Implant, Eye Sphere), HOY (Shield, eye, ophthalmic (including sunlamp protective eyewea)

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.

How do I get quotes?

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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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