- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jun 25, 2026
B-2-1397HQ-6D HEMATOLOGY CONTROLS is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by URIT Medical Electronic Co.,Ltd.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-2-1397/D-2-1397
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103010501NORMAL BLOOD CONTROLS1 warning recorded — scroll inside the panel to see all entries.
POTENTIAL BIOHAZARDOUS MATERIAL. For in vitro diagnostic use. Each human donor/unit used in the preparation of this product has been tested by a FDA licensed method/test and found to be negative or non- reactive for the presence of HBsAg, Anti-HCV, NAT testing for HIV-1, HCV (RNA) and HIV-1/2. Each unit is also negative by a serological test for Syphilis (RPR or STS). Because no test method can offer complete assurance that infectious agents are absent, this material should be handled as potentially infectious. When handling or disposing of vials follow precautions for patient specimens as specified in the OSHA Bloodborne Pathogen Rule (29 CFR Part 1910, 1030) or other equivalent biosafety procedures.
CN-MF-000011840Primary placement in Poland; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
| Italy | — | Still on market |
| Romania | — | 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 →Certificate health across this manufacturer's portfolio.
G10 074544 0020CancelledNotified 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 →No certificate specifically references this device's Basic UDI-DI.
69357407IUCS000003QQOn the marketHQ-3DIFF HEMATOLOGY CONTROLSB-2-1193On the marketHQ-5DIFF HEMATOLOGY CONTROLSB-2-1295On the marketHQ-CAL HEMATOLOGY CALIBRATORB-2-1499On the marketLaserVision Urine Sediment AnalyzerB-7-16YOn the marketMaintenance agent for Urine Analyzer69357407IUCS000004QSOn the market