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EUDAMED last updated this device on Sep 13, 2023
4046681151040VRMedi-Test Combi 5 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by MACHEREY-NAGEL GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
DE-MF-000005636IX 1038121-2(01)04046681000171
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
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 11 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Sep 13, 2023 | Still on market |
| Austria | Sep 13, 2023 | Still on market |
| Belgium | Sep 13, 2023 | Still on market |
| Spain | Sep 13, 2023 | Still on market |
| France | Sep 13, 2023 | Still on market |
| Hungary | Sep 13, 2023 | Still on market |
| Ireland | Sep 13, 2023 | Still on market |
| Italy | Sep 13, 2023 | Still on market |
| Luxembourg | Sep 13, 2023 | Still on market |
| Malta | Sep 13, 2023 | Still on market |
| Netherlands | Sep 13, 2023 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04046681000171Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
4046681151040VR93032UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101060201URINE SINGLE TEST STRIPS (INCL. TABLETS)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.
IX 1038121-2IssuedIX 1038121-3IssuedIX 1038121-4IssuedHX 1038121-1IssuedIX 1038121-1IssuedNotified 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 →Notified 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 →Notified 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 →Notified 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 →Notified 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 →