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Unimark fbk orange V=50 Superior

by Paul Marienfeld GmbH & Co. KG

Ref 0704502

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04250317301840 UDI-DI Date25 Apr 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number4250317302OTMSUX Basic UDI-DI 04250317301840UDI-DIDate23 Jun 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  • Withdrawn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
Unimark fbk orange V=50 Superior EUDAMED
Marienfeld Superior GUDID
Generic Name
General specimen microscopy slide IVD, single-use
Device Name
General specimen microscopy slide (IVD)
Model / Ref / Catalog
0704502, UniMark ground edges orange
Primary DI / UDI-DI
04250317301840
Basic UDI-DI
4250317302OTMSUX
Unit of Use DI
04250317379993
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
0704502
GUDID
UniMark ground edges orange
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000023724

Related devices

Category: General specimen microscopy slide IVD, single-use

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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