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OtoClear® Irrigation Tips 7200ST

by Bionix, LLC

OtoClear Irrigation Tips 7200ST is an ear canal irrigation tip (FDA Class I; FDA product code KCP, Syringe, Ent) made by Bionix, LLC, registered in EUDAMED and listed in FDA GUDID since 7 Jan 2022 (UDI-DI 00859911004870), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00859911004870 UDI-DI Date7 Jan 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 00859911004870 listed 7 Jan 2022 Listed

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
OtoClear® Irrigation Tips
Generic name
Ear canal irrigation tip
Model / Ref / Catalog
7200ST
Primary DI / UDI-DI
00859911004870
FDA product code
KCP
GMDN term
Ear canal irrigation tip
Device class
Class I
Regulation number
874.5220
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ear canal irrigation tip

Similar devices

Also classified as Ear canal irrigation tip.

Similar devices

Other devices filed under FDA product code KCP (SYRINGE, ENT).

Other devices from Bionix, LLC

See all devices from Bionix, LLC →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)