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EUDAMED last updated this device on Jun 3, 2026
B-054200408156344SURE Level 1 KETONE CONTROL SOLUTION is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by ForaCare Suisse AG. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05420040815634B-05420040815634ACS027(01)05420040815634
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101050299SPECIFIC CONTROLS (CC) - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in Ireland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | Still on market |
CH-MF-000019906No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.V1 092658 0004B-07640143656486On the market4SURE BLOOD GLUCOSE TEST STRIPSB-05420040815580On the market4SURE BLOOD GLUCOSE TEST STRIPSB-05420040815573On the market4SURE Level 1 Blood Glucose Control SolutionB-05420040815603On the market4SURE Level 2 Blood Glucose Control SolutionB-05420040815610On the market