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Irrigation Handpiece

by Duckworth & Kent Ltd. 4 variants

Ref 8-650-2

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055313832560 Basic UDI-DI 05055313832560UDI-DIDate24 Sep 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number05055313832560 UDI-DI Date31 Aug 2022ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Duckworth & Kent
Generic Name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Model / Ref / Catalog
8-650-2
Primary DI / UDI-DI
05055313832560
Basic UDI-DI
B-05055313832560
FDA Product Code
HMX
EMDN Code
L179004 Ocular irrigation or suction handpieces, reusable
GMDN Term
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.4350
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
GB-MF-000002176
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Duckworth & Kent Ltd.

See all devices from Duckworth & Kent Ltd. →

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No