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EUDAMED last updated this device on Jan 12, 2026
69357407IBHS000026EEURIT CA 11 Hematology Calibrator is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by URIT Medical Electronic Co.,Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06935740749558/(01)06935740749558
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103010507WHOLE BLOOD CALIBRATORSCN-MF-000011840The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | 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 0020IssuedNotified 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 →69357407IUCS000014QVOn the marketURIT 5L 31 Lyse69357407IBHS000033EBOn the marketURIT CA 11 Hematology Calibrator69357407IBHS000026EEOn the marketURIT D43 Probe Cleaner69357407IBHS000002DYOn the marketURIT L21 Lytic Reagent69357407IBHS000003E2On the marketURIT-2900Plus Automated Hematology AnalyzerB-2-269On the marketNo certificate specifically references this device's Basic UDI-DI.