- Role
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- Date of registration
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EUDAMED last updated this device on May 14, 2026
B-KR-MF-000015786HBXUPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →QUCARE® Pro Hemoglobin test strip is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by DFI Co.,Ltd.. Placed on the EU market in Denmark. 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 →D-KR-MF-000015786HBXUBasic 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-KR-MF-000015786HBXU6092UDI 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 →D-KR-MF-000015786HBXU
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101060199BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHERSterile
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 Denmark; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Jan 1, 2015 | Still on market |
KR-MF-000015786Certificate health across this manufacturer's portfolio.
HX 2028254-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →B-KR-MF-000015786BUNBMOn the marketQUCARE® Pro Blood Uric Acid test stripB-KR-MF-000015786BUAATOn the marketQUCARE® Pro Creatinine test stripB-KR-MF-000015786CREAXOn the marketQUCARE® Self Total cholesterol test stripB-KR-MF-000015786VTCDYOn the marketQUCARE® Self Triglyceride test stripB-KR-MF-000015786VTGE8On the marketUriDoctor 11B-KR-MF-000015786CYSelfQMOn the market