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sequencing system

by Bgi Europe a/S

Ref BGISEQ-500Model BGI SEQ-500

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5745000468BGISEQ-500PX Basic UDI-DI 05745000468157UDI-DIDate13 Jul 2022RegisteredStatusActive

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  • Withdrawn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
sequencing system
Model / Reference
BGI SEQ-500, BGISEQ-500
Primary DI / UDI-DI
05745000468157
Basic UDI-DI
5745000468BGISEQ-500PX
Direct Marketing DI
05745000468157
EMDN Code
W0105900102, W02050192
Device Class
Class A
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Other devices from Bgi Europe a/S

See all devices from Bgi Europe a/S →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
  • Surgical Instrument

Other properties (6)

  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No