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4SURE Level 1 Blood Glucose Control Solution

by ForaCare Suisse AG

Ref ACS017

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05420040815603 Basic UDI-DI 05420040815603UDI-DIDate3 Jun 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  • Withdrawn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
Blood Glucose Control Solution
Model / Reference
ACS017
Primary DI / UDI-DI
05420040815603
Basic UDI-DI
B-05420040815603
EMDN Code
W0101050205 Diabetes controls
Device Class
Class IVD Annex II List B
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CH-MF-000019906
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from ForaCare Suisse AG

See all devices from ForaCare Suisse AG →

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