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Mellinger Eye Speculum

by Bausch & Lomb GmbH 2 variants

Ref E4073

Mellinger Eye Speculum (E4073) is a Class I device made by Bausch & Lomb GmbH, registered in EUDAMED on 29 Apr 2026 (Basic UDI-DI B-04058935013707) and listed in FDA GUDID since 10 Jul 2025 (UDI-DI 04058935013707), active as of 22 Oct 2026.

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

CE MDD

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
European UnionCE/MDD EUDAMED NumberB-04058935013707 Basic UDI-DI 04058935013707UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04058935013707 UDI-DI Date10 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04058935013707 registered 29 Apr 2026 Active
  • FDA GUDID UDI-DI 04058935013707 listed 10 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04058935013707
  2. Registered EUDAMED B-04058935013707

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Eyelid speculum, reusable
Device name
Eye Speculum
Model / reference
E4073
Primary DI / UDI-DI
04058935013707
Basic UDI-DI
B-04058935013707
FDA product code
HNC
EMDN code
L17010199 Ocular dilators, reusable - other
GMDN term
Eyelid speculum, reusable
Device class
Class I
Regulation number
886.4350
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
DE-MF-000009142

Similar devices in this category

Other devices filed under OPHTHALMOLOGY DILATORS AND RETRACTORS, REUSABLE.

Other devices from Bausch & Lomb GmbH

See all devices from Bausch & Lomb GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (17, all answered No)