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RAL Stainer 405000

by R.A.L. Diagnostics

Ref 405000

RAL Stainer 405000 is a device classified as Class A in the EU and Class I in the US made by R.A.L. Diagnostics, registered in EUDAMED on 18 Sep 2026 (Basic UDI-DI 376017719405000HP) and listed in FDA GUDID since 10 Jul 2026 (UDI-DI 03760177194199), active as of 24 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number376017719405000HP Basic UDI-DI 03760177194199UDI-DIDate18 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760177194199 UDI-DI Date10 Jul 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376017719405000HP registered 18 Sep 2026 Active
  • FDA GUDID UDI-DI 03760177194199 listed 10 Jul 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760177194199
  2. Registered EUDAMED 376017719405000HP

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  • Withdrawn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
RAL Stainer
Generic name
Microscope slide stainer IVD
Model / reference
405000
Primary DI / UDI-DI
03760177194199
Basic UDI-DI
376017719405000HP
FDA product code
KPA
EMDN code
W0202059002 Automated slide stainers
GMDN term
Microscope slide stainer IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.3800
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Similar devices in this category

Other devices filed under AUTOMATED SLIDE STAINERS.

Other devices from R.A.L. Diagnostics

See all devices from R.A.L. Diagnostics →

Properties

  • IVD instrument
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)