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Gill 1 Hematoxylin

by Richard-Allan Scientific LLC 4 variants

Ref 6765006

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
European UnionCE/IVDR EUDAMED Number0673693RAS028RT Basic UDI-DI 00673693228442UDI-DIDate25 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00673693228442 UDI-DI Date3 Sep 2024ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Gill 1 Hematoxylin EUDAMED
Epredia GUDID
Generic Name
Biological stain IVD
Device Name
Histology Stains
Model / Ref / Catalog
6765006, Gill 1 Hematoxylin (Series S)
Primary DI / UDI-DI
00673693228442
Basic UDI-DI
0673693RAS028RT
Direct Marketing DI
00673693228442
FDA Product Code
HYJ
EMDN Code
W0103010301 Histo / cyto stains
GMDN Term
Biological stain IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.1850
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
6765006
GUDID
Gill 1 Hematoxylin (Series S)
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

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

Other devices from Richard-Allan Scientific LLC

See all devices from Richard-Allan Scientific LLC →

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