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PA-100 Analyzer

by Sysmex Astrego AB EUDAMED

Active European Union

Ref BP791314

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number735015506PA100XT Basic UDI-DIDate7 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

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-100 Analyzer
Model / Reference
BP791314
Primary DI / UDI-DI
07350155060002
Basic UDI-DI
735015506PA100XT
Direct Marketing DI
07350155060002
EMDN Code
W02030199 Antibiotic susceptibility analysers - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
SE-MF-000035496

Other devices from Sysmex Astrego AB

Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (7)

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