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DE-MF-000020368ViraClear is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Viramed Biotech AG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 24, 2022
++EVIRReagentwithoutCoT8PPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
EVIRUVNPPC1
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
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 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | May 26, 2022 | Still on market |
| Austria | May 26, 2022 | Still on market |
| Belgium | May 26, 2022 | Still on market |
| Bulgaria | May 26, 2022 | Still on market |
| Cyprus | May 26, 2022 | Still on market |
| Czechia | May 26, 2022 | Still on market |
| Denmark | May 26, 2022 | Still on market |
| Estonia | May 26, 2022 | Still on market |
| EL | May 26, 2022 | Still on market |
| Spain | May 26, 2022 | Still on market |
| Finland | May 26, 2022 | Still on market |
| France | May 26, 2022 | Still on market |
| Croatia | May 26, 2022 | Still on market |
| Hungary | May 26, 2022 | Still on market |
| Ireland | May 26, 2022 | Still on market |
| Iceland | May 26, 2022 | Still on market |
| Italy | May 26, 2022 | Still on market |
| Liechtenstein | May 26, 2022 | Still on market |
| Lithuania | May 26, 2022 | Still on market |
| Luxembourg | May 26, 2022 | Still on market |
| Latvia | May 26, 2022 | Still on market |
| Malta | May 26, 2022 | Still on market |
| Netherlands | May 26, 2022 | Still on market |
| Norway | May 26, 2022 | Still on market |
| Poland | May 26, 2022 | Still on market |
| Portugal | May 26, 2022 | Still on market |
| Romania | May 26, 2022 | Still on market |
| Sweden | May 26, 2022 | Still on market |
| Slovenia | May 26, 2022 | Still on market |
| Slovakia | May 26, 2022 | Still on market |
| Türkiye | May 26, 2022 | Still on market |
| XI | May 26, 2022 | 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.
EVIRUVNPPC1Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
++EVIRReagentwithoutCoT8PV-UVNPPCUDI 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.
W0105900201BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETCNo certificate specifically references this device's Basic UDI-DI.
++EVIRConjugate5EOn the marketViraChip® AP-Anti-Human IgM Conjugate++EVIRConjugate5EOn the marketViraChip® Reader++EVIRLaboratoryDeviceFPOn the marketViraScan Software++EVIRSoftware98On the marketViraSorb++EVIRReagentwithCoTQBOn the marketViraSorb++EVIRReagentwithCoTQBOn the marketNo 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.