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Zinc Buffered Formalin

by Richard-Allan Scientific LLC EUDAMEDGUDID

Active European Union

Ref 5705ZF

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0673693RAS006RH Basic UDI-DIDate15 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00673693177788 UDI-DIDate24 Jul 2024ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Zinc Buffered Formalin EUDAMED
Epredia GUDID
Generic Name
Neutral buffered formalin IVD
Device Name
Histology Fixatives
Model / Ref / Catalog
5705ZF, Zinc Buffered Formalin
Primary DI / UDI-DI
00673693177788
Basic UDI-DI
0673693RAS006RH
Direct Marketing DI
00673693177788
FDA Product Code
LDY
EMDN Code
W01030705 Fixing reagents (histology/cytology)
GMDN Term
Neutral buffered formalin IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.4010
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5705ZF
GUDID
Zinc Buffered Formalin
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000008261
Authorised representative
Epredia Netherlands B.V. NL-AR-000001488

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Properties

  • Single Use
  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

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