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Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5 3269.D05

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Ref 3269.D05

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08717872009407 Basic UDI-DI 08717872009407UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717872009407 UDI-DI Date23 Sep 2016ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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

Trade Name
Endoillumination Probe, including illuminated scleral depressor (25 gauge / 0.5 mm) EUDAMED
Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5 GUDID
Generic Name
Ophthalmic fibreoptic light instrument, single-use
Model / Ref / Catalog
3269.D05
Primary DI / UDI-DI
08717872009407
Basic UDI-DI
B-08717872009407
510(k) Number
FDA Product Code
MPA
EMDN Code
Z12129085 Various ophtalmology instruments - consumables
GMDN Term
Ophthalmic fibreoptic light instrument, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Ophthalmic fibreoptic light instrument, single-use

Cleared under the same submission (K062895)

Show all (12)

Other devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No