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BeneCheck Glucose Test Strip

by General Life Biotechnology Co., Ltd. 2 variants

Ref BK1-G, BK6-G, BK3-G, BK3-G2, BK3-G1

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-BK1-GS7 Basic UDI-DI Date19 Mar 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  • Withdrawn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

Device Name
Glucose Test Strip
Model / Reference
BK1-G, BK6-G, BK3-G, BK3-G2, BK3-G1
Primary DI / UDI-DI
D-BK1-GS7, D-BK6-GSY, D-BK3-GSH, D-BK3-G24Z, D-BK3-G14X
Basic UDI-DI
B-BK1-GS7, B-BK6-GSY, B-BK3-GSH, B-BK3-G24Z, B-BK3-G14X
EMDN Code
W0101060101 Glucose test strips
Device Class
Class IVD Annex II List B
EU market of registration
Germany

Manufacturer details

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

Other devices from General Life Biotechnology Co., Ltd.

See all devices from General Life Biotechnology Co., Ltd. →

Properties

  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No
  • Surgical Instrument: No