Skip to content

IOL Manipulator

by Duckworth & Kent Ltd. United Kingdom EUDAMEDGUDID

Ref 6-400-1

Product code HNQEMDN L1709

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055313822417 Basic UDI-DIDate23 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05055313822417 UDI-DIDate31 Aug 2022ListedStatusListed

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Duckworth & Kent
Generic Name
Ophthalmic surgical probe, reusable
Model / Ref / Catalog
6-400-1
Primary DI / UDI-DI
05055313822417
Basic UDI-DI
B-05055313822417
FDA Product Code
HNQ
EMDN Code
L1709 Ocular implant instruments not included in other classes, reusable
GMDN Term
Ophthalmic surgical probe, reusable
Device Class
Class I
Regulation Number
886.4350
Commercial Distribution
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 9ea7f522-e6cc-4d68-9e68-8c77baea3cf5 61 fields · synced 23 Oct 2026
  • FDA UDI fce014ad-84b0-478d-94db-857548002ac0 36 fields · synced 25 May 2026