Consulting Wallah › Device Explorer › Other devices › Ear speculum, single-use
Device Explorer · FDA GUDID · GMDN 34897

Ear speculum, single-use

A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the e

US‑registered devices193in commercial distribution
Companies24labelers on GUDID
Single‑use81%of device records
Sterile32%labelled sterile
Prescription55%Rx‑only share
ShareLinkedIn

Share of device records

Dtr Medical Limited5528%
Jedmed Instrument Company2010%
Heine Optotechnik Gmbh & Co. Kg168%
North Eos Industries Inc.158%
Exmoor Plastics Limited147%
Bv Medical126%
American Diagnostic Corp105%
Kirchner & Wilhelm Gmbh + Co Kg84%

Top labelers

CompanyDevicesShare
Dtr Medical Limited5528%
Jedmed Instrument Company2010%
Heine Optotechnik Gmbh & Co. Kg168%
North Eos Industries Inc.158%
Exmoor Plastics Limited147%
Bv Medical126%
American Diagnostic Corp105%
Kirchner & Wilhelm Gmbh + Co Kg84%
Spiggle & Theis Medizintechnik Gmbh53%
Hopkins Uniform Company53%
North American Rescue, Llc42%
Gyrus Acmi, Llc42%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sterile Tumarkin Ear Specula Sample SetSterile Rosen Ear Specula Sample SetTumarkin Ear Specula size 4 (7.0mm)Tumarkin Ear Specula size 3 (6.5mm)Tumarkin Ear Specula size 2 (6.0mm)Tumarkin Ear Specula size 1 (5.5mm)Tumarkin Ear Specula size 0.5 (4.5mm)Tumarkin Ear Specula size 0 (3.5mm)Single-use Tumarkin Ear Specula size 4 (7.0mm) nSingle-use Tumarkin Ear Specula size 3 (6.5mm) nSingle-use Tumarkin Ear Specula size 2 (6.0mm) nSingle-use Tumarkin Ear Specula size 0.5 (4.5mm)Single-use Tumarkin Ear Specula size 0 (3.5mm) nShea Ear Specula Size 4 (6.5mm x 8.5mm)Shea Ear Specula Size 3 (5.5mm x 7.5mm)Shea Ear Specula Size 2 (4.5mm x 5.5mm)

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

FDA product codes

CodeNameDevices
EPYSpeculum, Ent125
FXGSpecula Accessories21
ERAOtoscope18
EPYSPECULUM, ENT8
ERAOTOSCOPE7
JYKHOLDER, EAR SPECULUM4

GMDN & GCC registration

  • GMDN code 34897 · non‑implantable
  • Single‑use 81% · sterile 32% · Rx‑only 55% · OTC 15%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 9Outer Diameter (Millimeter) · 8Outer Diameter (Centimeter) · 2

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

How many ear speculum, single-use products are registered in the US?

193 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ear speculum, single-use", from 24 companies. The largest labeler is Dtr Medical Limited with 28% of records.

Which FDA product codes apply?

EPY (Speculum, Ent), FXG (Specula Accessories), ERA (Otoscope), EPY (SPECULUM, ENT)

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 ear speculum, single-use 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 Ear speculum, single-use

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 ear speculum, single-use 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 →