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Acid Wash Solution (Aws)

by Randox Laboratories Limited 2 variants

Ref WS3853

Acid Wash Solution (Aws) (WS3853) is a device classified as Class A in the EU and Class I in the US made by Randox Laboratories Limited, registered in EUDAMED on 20 Sep 2023 (Basic UDI-DI 50552732AAWSOLN001P8) and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 05055273206982), 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 Number50552732AAWSOLN001P8 Basic UDI-DI 05055273206982UDI-DIDate20 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number05055273206982 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 50552732AAWSOLN001P8 registered 20 Sep 2023 Active
  • FDA GUDID UDI-DI 05055273206982 listed 26 Sep 2016 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 05055273206982
  2. Registered EUDAMED 50552732AAWSOLN001P8

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  • Withdrawn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
Acid Wash Solution (Aws) EUDAMED
Aws GUDID
Generic name
Wash/cleaning solution IVD, automated/semi-automated system
Model / Ref / Catalog
WS3853
Primary DI / UDI-DI
05055273206982
Basic UDI-DI
50552732AAWSOLN001P8
FDA product code
JJF
EMDN code
W0201010185 Chemistry analysers - consumables
GMDN term
Wash/cleaning solution IVD, automated/semi-automated system
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2170
EU registration type
Standard device
EU market of registration
Northern Ireland
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.

Manufacturer details

EUDAMED SRN
XI-MF-000028410

Similar devices in this category

Other devices filed under CHEMISTRY ANALYSERS - CONSUMABLES.

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Properties

  • Single use
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)