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EUDAMED last updated this device on Dec 16, 2025
0850624008CCEtG302HJEthyl Glucuronide 200 Semi-Quantitative Calibrators Set is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Lin-Zhi International, Inc.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0085062400859909976493190US-MF-000003373(01)00850624008599
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
7 warnings recorded — scroll inside the panel to see all entries.
This solution is prepared from non-sterile human urine and should be handled as potentially infectious.
Do not use the product beyond the expiration date. See the expiration date on individual bottle labels.
Harmful if swallowed.
Biohazard symbol on the label.
OTHER
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 | Dec 19, 2025 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102152209DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORSPrimary 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 →0850624008EIABUP02C9On the marketEthyl Glucuronide 200 Control Set0850624008CCEtG302HJOn the marketEthyl Glucuronide 200 Qualitative Calibrator Set0850624008CCEtG302HJOn the marketEthyl Glucuronide 500 Control Set0850624008CCEtG302HJOn the marketEthyl Glucuronide 500 Qualitative Calibrator Set0850624008CCEtG302HJOn the marketEthyl Glucuronide 500 Semi-Quantitative Calibrators Set0850624008CCEtG302HJOn the marketNo certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.