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Panbio™

by Abbott Diagnostics Korea Inc.

Ref 01PE10

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800037004079 Basic UDI-DI 08800037004079UDI-DIDate20 Aug 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
01PE10
Primary DI / UDI-DI
08800037004079
Basic UDI-DI
B-08800037004079
EMDN Code
W0105020202 Hepatitis b surface antigen - confirmatory
Device Class
Class IVD General
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000025193
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties

  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No