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Device Explorer · FDA GUDID · GMDN 11585

ENT examination/treatment system

An assembly of devices intended to support a patient in a supine or reclining position and provide specialized features for an ear/nose/throat (ENT) examination or treatment. It typically includes a table and/or chair and functional components such as a suctio

US‑registered devices54in commercial distribution
Companies9labelers on GUDID
Single‑use24%of device records
Sterile0%labelled sterile
Prescription41%Rx‑only share
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Share of device records

Rudolf Riester Gmbh2139%
Novo Surgical, Inc.1222%
Optomic España Sa713%
Happersberger Otopront Gmbh611%
Haag-Streit Usa, Inc.47%
Hermann Medizintechnik Gmbh12%
Gyrus Acmi, Llc12%
Avalign Technologies, Inc.12%

Top labelers

CompanyDevicesShare
Rudolf Riester Gmbh2139%
Novo Surgical, Inc.1222%
Optomic España Sa713%
Happersberger Otopront Gmbh611%
Haag-Streit Usa, Inc.47%
Hermann Medizintechnik Gmbh12%
Gyrus Acmi, Llc12%
Avalign Technologies, Inc.12%
Icu Medical, Inc.12%

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

Brand names on the register (sample)

OTOPRONTHermann Medizintechnik GmbHWall diagnostic ri-former® 1 handle 3.5 V / 120 Wall diagnostic ri-former® 1 handle 3.5 V / 230 ri-former® diagnostic station, mobile, 2 handelsri-former® diagnostic station with mobile base, ri-former® diagn. station for rail, 2 handles, 3ri-former® diagnostic station, mobile, 2-handlesri-former® diagnostic station, with mobile base,ri-former® diagn. station for rail, 2 handles, ri-former® wall diagnostic station 3,5 V/230 V, ri-former® wall diagnostic station, 3.5 V / 120 ri-former® wall diagnostic station 3.5 V/120 V, Diagnostic station ri-former® 2 handles, 3 pin-pWall diagnostic ri-former® 2 handles 3.5 V / 120Wall diagnostic ri-former® 2 handles 3.5 V / 230

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

FDA product codes

CodeNameDevices
HLJOphthalmoscope, Battery-Powered21
ETFUnit, Examining/Treatment, Ent17
KAIMirror, Ent12
LRCInstrument, Ent Manual Surgical1
LRCINSTRUMENT, ENT MANUAL SURGICAL1
NWWHysteroscope accessories1

GMDN & GCC registration

  • GMDN code 11585 · non‑implantable
  • Single‑use 24% · sterile 0% · Rx‑only 41% · 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 ent examination/treatment system products are registered in the US?

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "ENT examination/treatment system", from 9 companies. The largest labeler is Rudolf Riester Gmbh with 39% of records.

Which FDA product codes apply?

HLJ (Ophthalmoscope, Battery-Powered), ETF (Unit, Examining/Treatment, Ent), KAI (Mirror, Ent), LRC (Instrument, Ent Manual Surgical)

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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