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BeneCheck Uni Total Cholesterol Monitoring System

by General Life Biotechnology Co., Ltd.

Ref BSC01D, BSC010, BSC02D, BSC020

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-BSC01DAL Basic UDI-DI Date2 Feb 2023RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
Total cholesterol monitoring system
Model / Reference
BSC01D, BSC010, BSC02D, BSC020
Primary DI / UDI-DI
D-BSC01DAL, D-BSC0109E, D-BSC02DAP, D-BSC0209H
Basic UDI-DI
B-BSC01DAL, B-BSC0109E, B-BSC02DAP, B-BSC0209H
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class IVD devices for self-testing
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000027109
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Self Testing
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Companion Diagnostics: No