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BG-201 Blood Glucose Monitoring System

by Sejoy Biomedical Co., Ltd.

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06939663922555 Basic UDI-DI 06939663922555UDI-DIDate28 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Primary DI / UDI-DI
06939663922555
Basic UDI-DI
B-06939663922555
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class IVD Annex II List B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000008447
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Sejoy Biomedical Co., Ltd.

See all devices from Sejoy Biomedical Co., Ltd. →

Properties

  • Self Testing
  • Professional Testing
  • Surgical Instrument

Other properties (7)

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