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EUDAMED last updated this device on Jun 3, 2026
B-05420040815610Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →4SURE Level 2 Blood Glucose Control Solution is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by ForaCare Suisse AG. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →05420040815610Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →B-05420040815610ACS018UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →(01)05420040815610
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101050205DIABETES CONTROLS1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →No 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 1 KETONE CONTROL SOLUTIONB-05420040815634On the market