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Atellica DT Solution 3 (S3)

by Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság

Ref 11310505Model VA0000SL

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05999883586853 UDI-DI Date30 Apr 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number5999883586CLEVK Basic UDI-DI 05999883586853UDI-DIDate20 May 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Wash/cleaning solution IVD, automated/semi-automated system
Device Name
Cleaning Solution
Model / Ref / Catalog
VA0000SL, 11310505, Atellica DT Solution 3 (S3)
Primary DI / UDI-DI
05999883586853 EUDAMED
15999883586850 GUDID
Basic UDI-DI
5999883586CLEVK
FDA Product Code
JCB
EMDN Code
W0599 IVD general use consumable devices - other
GMDN Term
Wash/cleaning solution IVD, automated/semi-automated system
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.4010
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
VA0000SL
11310505
GUDID
Atellica DT Solution 3 (S3)
Primary DI / UDI-DIEUDAMED
05999883586853
GUDID
15999883586850
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
HU-MF-000020416

Other devices from Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

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Properties

  • Reagent
  • Professional Testing
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No