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Mellinger Eye Speculum

by Bausch & Lomb GmbH 2 variants

Ref E4072

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04058935012656 Basic UDI-DI 04058935012656UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04058935012656 UDI-DI Date10 Jul 2025ListedStatusListed GUDID: 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Eyelid speculum, reusable
Device Name
Eye Speculum
Model / Reference
E4072
Primary DI / UDI-DI
04058935012656
Basic UDI-DI
B-04058935012656
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 market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Contains LatexEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
DE-MF-000009142

Other devices from Bausch & Lomb GmbH

See all devices from Bausch & Lomb GmbH →

Properties

  • Reusable
  • Contains Latex YesEUDAMEDNoGUDID
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (16)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Expiration Date: No