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EUDAMED last updated this device on Jun 3, 2026
B-4-16H/ is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List 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.
D-4-16H/D-4-16H
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101060101GLUCOSE TEST STRIPSPrimary 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.
B-6-111F5On the market"REF: USIA00000083M, USIA00000084M"B-6-88B2On the market"REF: USIA00000059M, USIA00000060M"B-6-54AHOn the market"REF: USIA00000127M, USIA00000128M"B-6-79AZOn the market"REF: USCA00000774, USCA00000778 USCA00000775 USCA00000737 USCA00000776 USCA00000738 USCA00000777 USCA00000739"B-6-130F9On the market"REF: U81282040M, U81289040M, U81285020M, U81211020M, U81220040M"B-6-41A8On the marketNo certificate specifically references this device's Basic UDI-DI.