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EUDAMED last updated this device on Jun 18, 2026
B-07640143658145FORA Control Solution BG Level 2 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 Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07640143658145ACS018(01)07640143658145
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101050205DIABETES CONTROLS1 warning recorded — scroll inside the panel to see all entries.
CW010CH-MF-000019906V1 092658 0004Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
Sterile
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 →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 →Basic 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 →UDI 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 →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 →No 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.B-07640402710324On the marketFORA 6 𝝱-Ketone Test StripB-07640143650118On the marketFORA 6 𝝱-Ketone Test StripB-07640143659074On the marketFORA Control Solution BG Level 3B-07640143658152On the marketFORA Control Solution KB Level 2B-07640143658299On the marketFORA Control Solution TCH NormalB-07640143658220On the marketNo certificate specifically references this device's Basic UDI-DI.