- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 30, 2026
B-08594036044029ELISA-VIDITEST anti-CMV IgM is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by VIDIA spol. s r.o.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08594036044029OD-402(01)08594036044029
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105040204CMV IGM6 warnings recorded — scroll inside the panel to see all entries.
CW083CW105CW167CW422CW306Primary placement in Czechia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
CZ-MF-000036964No. 20 0415 QS/NBCW272Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
B-08594036041776On the marketELISA-VIDITEST anti-CMV IgG and IgG avidityB-28594036041770On the marketELISA-VIDITEST anti-CMV IgMB-28594036044023On the marketELISA-VIDITEST anti-EA (D) EBV IgAB-28594036042548On the marketELISA-VIDITEST anti-EA (D) EBV IgAB-08594036042544On the marketELISA-VIDITEST anti-EA (D) EBV IgGB-08594036040991On 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.