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Bgi

by Bgi Europe a/S 14 variants

Ref EU0200050008 (PBC22A Plus)Model PBC20， PBC20A， PBC22， PBC22A，PBC20 Plus, PBC20A Plus，PBC22 Plus，PBC22A Plus

Active European Union

CE IVDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5745000468EU02000500019R Basic UDI-DI 05745000468485UDI-DIDate17 Jan 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Automated clinical chemistry analyzer
Model / Reference
PBC20， PBC20A， PBC22， PBC22A，PBC20 Plus, PBC20A Plus，PBC22 Plus，PBC22A Plus, EU0200050008 (PBC22A Plus)
Primary DI / UDI-DI
05745000468485
Basic UDI-DI
5745000468EU02000500019R
EMDN Code
W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
Device Class
Class A
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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