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EUDAMED last updated this device on Mar 6, 2026
B-06944413815810Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Hematology Control is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Edan Instruments,Inc.. Placed on the EU market in Germany. 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 →06944413815810Basic 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-06944413815810ED-60D Control NUDI 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 →(01)06944413815810
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103010503MULTILEVEL BLOOD CONTROLS1 warning recorded — scroll inside the panel to see all entries.
CW011Sterile
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 Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
CN-MF-000009957No 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.69444138HematoryCon90DAZOn the marketHematology ControlB-06944413815773On the marketHematology ControlB-06944413815759On the marketHematology Control69444138HematoryCon90DAZOn the marketHolter ECG and ABP system69444138SA20SNMOn the marketHolter ECG and ABP system69444138SA20SNMOn the market