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Cleaning solution

by Diamond Diagnostics Inc 12 variants

Ref SM-B01418255D

Cleaning solution (SM-B01418255D) is a buffered wash solution IVD (EU IVDR Class A) made by DIAMOND DIAGNOSTICS Inc, registered in EUDAMED on 23 May 2024 (Basic UDI-DI 081140301SMB01418255DZT) and listed in FDA GUDID since 9 Jun 2023 (UDI-DI 00811403019007), 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 Number081140301SMB01418255DZT Basic UDI-DI 00811403019007UDI-DIDate23 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00811403019007 UDI-DI Date9 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081140301SMB01418255DZT registered 23 May 2024 Active
  • FDA GUDID UDI-DI 00811403019007 listed 9 Jun 2023 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 00811403019007
  2. Registered EUDAMED 081140301SMB01418255DZT

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  • Withdrawn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
Cleaning solution EUDAMED
Probe Wash 2 GUDID
Generic name
Buffered wash solution IVD
Device name
Probe Wash 2 ADVIA
Model / reference
SM-B01418255D
Primary DI / UDI-DI
00811403019007
Basic UDI-DI
081140301SMB01418255DZT
EMDN code
W01019099 Clinical chemistry reagents - other
GMDN term
Buffered wash solution IVD
Device class
Class A
EU registration type
Standard device
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000035435
Authorised representative
Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Similar devices in this category

Other devices filed under CLINICAL CHEMISTRY REAGENTS - OTHER.

Other devices from DIAMOND DIAGNOSTICS Inc

See all devices from DIAMOND DIAGNOSTICS Inc →

Properties

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