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CRE EU 16-well

by AusDiagnostics Pty Ltd

Ref 21099S

Active European Union

CE IVDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-09343044002656 Basic UDI-DI 09343044002656UDI-DIDate24 Oct 2023RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Step 1 tubes for CRE EU 16-well
Model / Reference
21099S
Primary DI / UDI-DI
09343044002656
Basic UDI-DI
B-09343044002656
EMDN Code
W0104080605, W0104080606
Device Class
Class IVD General
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
AU-MF-000020558
Authorised representative
Advena Limited MT-AR-000000234

Other devices from AusDiagnostics Pty Ltd

See all devices from AusDiagnostics Pty Ltd →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No