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EUDAMED last updated this device on Jun 3, 2026
B-4-86X/ 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 Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-4-86X/D-4-86X
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W010106010801BLOOD TEST STRIPS CONTROLSPrimary placement in Germany; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Italy | — | Still on market |
CN-MF-000011840Sterile
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 →B-6-22A4On the market"REF: U89482030M, U89489060M, U89485015M, U89411020M, U89420045M"B-6-109VOn the market"REF: USCA00000711, USCA00000712, USCA00000713, USCA00000714"B-6-21A2On the marketW01010306 "REF: USCA00000696, USCA00000697, USCA00000698, USCA00000699 "B-6-52ADOn the market"REF: USIA00000201M, USIA00000202M"B-6-118FKOn the market"REF: U84981030M, U84987050M, U84989050M, U84985020M, U84911020M, U84921050M "B-6-24A8On the marketNo certificate specifically references this device's Basic UDI-DI.
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.
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