- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 3, 2026
B-4-56R/ is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. 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-4-56R/D-4-56R
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201069099VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHERPrimary placement in Germany; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market | |
| Italy | Still on market |
CN-MF-000011840No.V1 0745440014Sterile
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.
No certificate specifically references this device's Basic UDI-DI.
B-6-74APOn the market"REF: USIA00000089M, USIA00000090M"B-6-60ACOn the market"REF: USIA00000149M, USIA00000150M"B-6-68AUOn the market"REF: USIA00000141M, USIA00000142M"B-6-72AKOn the market"REF: U88782020M, U88781040M, U88789060M, U88785020M, U88720060M"B-6-49AQOn the market"REF: USIA00000139M, USIA00000140M"B-6-69AWOn the market