Consulting Wallah › Device Explorer › Other devices › Self-retaining ear speculum
Device Explorer · FDA GUDID · GMDN 35348

Self-retaining ear speculum

A hand-held manual instrument which typically comprises two arms joined at a pivot point and designed for expanding or stretching the tissue around the ear orifice when inserted and opened. It has a blunt distal tip and is used for examination or surgery, typi

US‑registered devices236in commercial distribution
Companies10labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription81%Rx‑only share
ShareLinkedIn

Share of device records

Ambler Surgical Corp.11649%
Aesculap Ag3716%
Med Saver, Inc.2410%
The Trustee For Kaiser Family Trust2310%
Gimmi Gmbh146%
Adept Medical Limited125%
Vorotek Pty Ltd42%
Elite Medical Instrumentation31%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.11649%
Aesculap Ag3716%
Med Saver, Inc.2410%
The Trustee For Kaiser Family Trust2310%
Gimmi Gmbh146%
Adept Medical Limited125%
Vorotek Pty Ltd42%
Elite Medical Instrumentation31%
Peak Medical Distribution Inc.21%
Raw Surgical Corporation10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GimmiAESCULAPMSI Precision Specialty InstrumentsAmbler SurgicalEar Specula - 10mm Non-SterileEar Specula - 8mm Non-SterileEar Specula - 3mm Non-SterileEar Specula - 4mm Non-SterileEar Specula - 5mm Non-SterileEar Specula - 6mm Non-SterileINKAVorOtek SpeculumsELITE MEDICAL INSTRUMENTATIONRaw Surgical CorporationPEAK MEDICAL

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

FDA product codes

CodeNameDevices
EPYSPECULUM, ENT182
EPYSpeculum, Ent52
FXESpeculum, Non-Illuminated2
LRCINSTRUMENT, ENT MANUAL SURGICAL1
KAGHOLDER, SPECULUM, ENT1
KYZSYRINGE, IRRIGATING (NON DENTAL)1

GMDN & GCC registration

  • GMDN code 35348 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 81% · 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 self-retaining ear speculum products are registered in the US?

236 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Self-retaining ear speculum", from 10 companies. The largest labeler is Ambler Surgical Corp. with 49% of records.

Which FDA product codes apply?

EPY (SPECULUM, ENT), EPY (Speculum, Ent), FXE (Speculum, Non-Illuminated), 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?

Add self-retaining ear speculum to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Self-retaining ear speculum

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying self-retaining ear speculum for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →