Consulting Wallah › Device Explorer › Syringes, needles & infusion › Ear canal irrigation syringe
Device Explorer · FDA GUDID · GMDN 35025

Ear canal irrigation syringe

A device intended to be used to flush the ear canal with an irrigating solution. It is typically available in two main design mechanisms that are used to carefully exert pressure on the irrigating fluid: 1) a cylindrical barrel with a plunger that have finger

US‑registered devices114in commercial distribution
Companies23labelers on GUDID
Single‑use18%of device records
Sterile22%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Integra Lifesciences Production Corporation2118%
C. R. Bard, Inc.1211%
Ambler Surgical Corp.109%
Steris Corporation98%
Avaline Medical Nj Limited Liability Company76%
Novo Surgical, Inc.76%
Amsino International, Inc.65%
Bear-Ent, Llc65%

Top labelers

CompanyDevicesShare
Integra Lifesciences Production Corporation2118%
C. R. Bard, Inc.1211%
Ambler Surgical Corp.109%
Steris Corporation98%
Avaline Medical Nj Limited Liability Company76%
Novo Surgical, Inc.76%
Amsino International, Inc.65%
Bear-Ent, Llc65%
Bausch & Lomb Incorporated54%
Medline Industries, Inc.44%
Gf Health Products, Inc.44%
Ningbo Albert Novosino Co.,Ltd.33%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NoneHSW UNIVERSAL Selffilling ear syringeHSW UNIVERSAL Selffilling ear syringe complete sSymmetry SurgicalBR Surgical, LLCPremierProHCSAvaline Medical NJ LLCEar and Ulcer SyringeBausch + LombEar/Ulcer Bulb SyringeMSI Precision Specialty InstrumentsPOMEROY EAR SYRINGEMillenniumAmbler SurgicalAmerican Medicals

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

FDA product codes

CodeNameDevices
KYZSYRINGE, IRRIGATING (NON DENTAL)31
KCPSYRINGE, ENT31
KCPSyringe, Ent19
LRCINSTRUMENT, ENT MANUAL SURGICAL13
KYZSyringe, Irrigating (Non Dental)12
JYHEXCAVATOR, EAR7

GMDN & GCC registration

  • GMDN code 35025 · non‑implantable
  • Single‑use 18% · sterile 22% · Rx‑only 70% · 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

Total Volume (Fluid Ounce) · 15Total Volume (Milliliter) · 2

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

How many ear canal irrigation syringe products are registered in the US?

114 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ear canal irrigation syringe", from 23 companies. The largest labeler is Integra Lifesciences Production Corporation with 18% of records.

Which FDA product codes apply?

KYZ (SYRINGE, IRRIGATING (NON DENTAL)), KCP (SYRINGE, ENT), KCP (Syringe, 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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