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PA-AST Panel U-0501

by Sysmex Astrego AB EUDAMED

Active European Union

Ref CG860272

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07350155060026 Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
PA-AST Panel U-0501
Model / Reference
CG860272
Primary DI / UDI-DI
07350155060026
Basic UDI-DI
B-07350155060026
EMDN Code
W0104080113 Other automated susceptibility testing (incl consumables...)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
SE-MF-000035496

Other devices from Sysmex Astrego AB

Properties

  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No