- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jul 18, 2025
69357407IBHS000007EAURIT R11 Staining solution for Hematology Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. 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.
06935740723473/CN-MF-000011840(01)06935740723473
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
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.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103010102SPECIFIC RETICULOCYTE REAGENTSPrimary 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 certificate specifically references this device's Basic UDI-DI.
69357407IBHS000027EGOn the marketURIT QC 31 Reticulocyte Control69357407IBHS000027EGOn the marketURIT QC 31 Reticulocyte Control69357407IBHS000027EGOn the marketURIT S11 Sheath for Urine Analysis69357407IUSS00000127On the marketURIT-2900Plus Automated Hematology AnalyzerB-2-269On the marketURIT-3000Plus Automated Hematology Analyzer69357407IBH000005NFOn the marketCertificate 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 →