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EUDAMED last updated this device on Jun 9, 2025
69357407IBH000002N9BH-5100 5-Part-Diff Auto Hematology Analyzer 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.
06935740725293/(01)06935740725293
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0202010101AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)CN-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 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 →69357407IBF000001M5On the marketBF-730 B5R3V6 Flow Cytometer69357407IBF000001M5On the marketBH-40P Automated Hematology Analyzer69357407IBH000001N7On the marketBH-5160CRP 5-Part-Diff Auto Hematology Analyzer69357407IBH000003NBOn the marketBH-5160CS 5-Part-Diff Auto Hematology Analyzer69357407IBH000003NBOn the marketBH-51S 5-Part-Diff Auto Hematology AnalyzerB-2-66HOn the marketNo certificate specifically references this device's Basic UDI-DI.