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OT ~75x75x1 rw ubk oMR V=50 iPap Superior CE

by Paul Marienfeld GmbH & Co. KG

Ref 111109901

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

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
United StatesGUDID listing GUDID Number04250317339744 UDI-DI Date25 Apr 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number4250317302OTONUT Basic UDI-DI 04250317339744UDI-DIDate7 Dec 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
OT ~75x75x1 rw ubk oMR V=50 iPap Superior CE EUDAMED
Marienfeld Superior GUDID
Generic Name
General specimen microscopy slide IVD, single-use
Device Name
Special size microscopy Slides (IVD)
Model / Ref / Catalog
111109901, Microscope slides ~75x75x1 cut edges in paper
Primary DI / UDI-DI
04250317339744
Basic UDI-DI
4250317302OTONUT
Unit of Use DI
04250317382276
FDA Product Code
KEW
EMDN Code
W0503900201 Microscope slides
GMDN Term
General specimen microscopy slide IVD, single-use
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.3010
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
111109901
GUDID
Microscope slides ~75x75x1 cut edges in paper
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000023724

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Properties

  • Single Use
  • Surgical Instrument
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No