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Pbia-12A

by UIMD Inc. EUDAMED

Active European Union

Ref PBIA-12A

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880989836PBIA-12ACJ Basic UDI-DIDate13 Dec 2024RegisteredStatusActive

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  • Withdrawn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
Pbia-12A
Model / Reference
PBIA-12A
Primary DI / UDI-DI
08809898360003
Basic UDI-DI
880989836PBIA-12ACJ
Direct Marketing DI
08809898360003
EMDN Code
W02020199 Cell counting instruments - other
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000034633
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from UIMD Inc.

Properties

  • Human Tissues
  • Professional Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No