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EUDAMED last updated this device on Jun 11, 2024
B-08800065170005CERA-CHEK™ Hb Plus Hemoglobin Control Solution is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by GC MEDIS Corp.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08800065170005B400C10(01)08800065170005
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103010504HAEMOGLOBIN CONTROLS2 warnings recorded — scroll inside the panel to see all entries.
If ingested, contact your physician. Contact with the eyes or skin may cause irritation.
Keep the test meter and components away from children.
KR-MF-000012638V1 091763 0015Primary placement in Romania; available across 1 country total.
Placed on the market in Romania; 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.B-08800065106004On the marketCERA-CHEK™ 1Code Blood Glucose Test StripB-08800065124121On the marketCERA-CHEK™ 1Code Glucose Control SolutionB-08800065174003On the marketCERA-CHEK™ Hb Plus Hemoglobin Measuring SystemB-08800065152018On the marketCERA-CHEK™ Hb Plus Hemoglobin Test StripB-08800065140022On the marketCERA-CHEK™ Lactate Control SolutionB-08800065181100On the marketNo certificate specifically references this device's Basic UDI-DI.