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4sure Β -Ketone Test Strips

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref ACS053

by ForaCare Suisse AG

Identity

Trade Name
4SURE β -KETONE TEST STRIPS EUDAMED
Device Name
𝝱 Ketone Test Strip EUDAMED
Model / Reference
ACS053 EUDAMED

Identifiers

Primary DI / UDI-DI
05420040815597 EUDAMED
Basic UDI-DI
B-05420040815597 EUDAMED
EMDN Code
W0101060110 KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Market of Registration
Ireland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

4sure Β -Ketone Test Strips by ForaCare Suisse AG — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
ForaCare Suisse AG
EUDAMED SRN
CH-MF-000019906
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

  • EUDAMED 2fa2c016-36e3-4b9d-a76f-ab2a587838e2 61 fields · synced Jul 25, 2026