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Cell-Fixx™

by Richard-Allan Scientific LLC

Part of a family of 16 devices: see the family page

Ref 6768326

Cell-Fixx™ (6768326) is a device classified as Class A in the EU and Class I in the US made by Richard-Allan Scientific LLC, registered in EUDAMED on 26 Jan 2026 (Basic UDI-DI 0673693RAS005RF) and listed in FDA GUDID since 19 Jul 2024 (UDI-DI 00673693228640), active as of 22 Oct 2026.

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

CE IVDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0673693RAS005RF Basic UDI-DI 00673693228640UDI-DIDate26 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00673693228640 UDI-DI Date19 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0673693RAS005RF registered 26 Jan 2026 Active
  • FDA GUDID UDI-DI 00673693228640 listed 19 Jul 2024 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 00673693228640
  2. Registered EUDAMED 0673693RAS005RF

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  • Withdrawn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
Cell-Fixx™ EUDAMED
Epredia GUDID
Generic name
Cytology fixative solution IVD
Device name
Cytology Fixatives
Model / Ref / Catalog
6768326, Cell-Fixx
Primary DI / UDI-DI
00673693228640
Basic UDI-DI
0673693RAS005RF
Direct marketing DI
00673693228640
FDA product code
LEA
EMDN code
W01030705 Fixing reagents (histology/cytology)
GMDN term
Cytology fixative solution IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.4010
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
6768326
GUDID
Cell-Fixx
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Similar devices in this category

Other devices filed under FIXING REAGENTS (HISTOLOGY/CYTOLOGY).

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 (19, all answered No)