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EUDAMED last updated this device on Jul 22, 2024
B-08800065178001CERA-STAT™ HbA1c Control Solution is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by GC MEDIS Corp.. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08800065178001CS400C10(01)08800065178001
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101050205DIABETES CONTROLS2 warnings recorded — scroll inside the panel to see all entries.
For in vitro diagnostic use only. - Use gloves and protective accessories when handling CERA-STAT™ HbA1c Control Solution. - Handle with caution, as CERA-STAT™ HbA1c Control Solution may contaminate microorganisms and viruses during handling. - Discard the vial if there is any evidence of microbial or fungal contamination.
KR-MF-000012638Primary placement in Belgium; available across 1 country total.
Placed on the market in Belgium; per-country availability dates not published.
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.No certificate specifically references this device's Basic UDI-DI.