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STA® - Desorb U

by Diagnostica Stago

Ref 00975

STA® - Desorb U (00975) is a device classified as Class A in the EU and Class I in the US made by Diagnostica Stago, registered in EUDAMED on 17 Nov 2022 (Basic UDI-DI 3607450AUXI0006RW) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 13607450009757), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number3607450AUXI0006RW Basic UDI-DI 13607450009757UDI-DIDate17 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number13607450009757 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3607450AUXI0006RW registered 17 Nov 2022 Active
  • FDA GUDID UDI-DI 13607450009757 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 13607450009757
  2. Registered EUDAMED 3607450AUXI0006RW

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  • Withdrawn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

Generic name
Buffered wash solution IVD
Device name
Decontaminating Solution
Model / reference
00975
Primary DI / UDI-DI
13607450009757
Basic UDI-DI
3607450AUXI0006RW
Unit of use DI
03607450009750
FDA product code
PPM
EMDN code
W0103020999 Auxiliary reagents (haemostasis) - other
GMDN term
Buffered wash solution IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.4010
EU registration type
Standard device
EU market of registration
France
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
FR-MF-000017089

Similar devices in this category

Other devices filed under AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER.

Other devices from Diagnostica Stago

See all devices from Diagnostica Stago →

Properties

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