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Alkaline Washing Solution

by Biosystems S.A.

Ref AC17205

Alkaline Washing Solution (AC17205) is an in vitro diagnostic device (EU IVDR Class A; EMDN category chemistry analysers - consumables) made by Biosystems S.A., registered in EUDAMED on 29 Oct 2025 (Basic UDI-DI 8435287190ALKAWASHSoLM), active as of 24 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8435287190ALKAWASHSoLM Basic UDI-DI 08435287108477UDI-DIDate29 Oct 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Alkaline Washing Solution
Model / reference
AC17205
Primary DI / UDI-DI
08435287108477
Basic UDI-DI
8435287190ALKAWASHSoLM
EMDN code
W0201010185 Chemistry analysers - consumables
Device class
Class A
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000231

Similar devices in this category

Other devices filed under CHEMISTRY ANALYSERS - CONSUMABLES.

Other devices from Biosystems S.A.

See all devices from Biosystems S.A. →

Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (10, all answered No)