- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 29, 2026
B-38594036043016MONO-VIDITEST anti-Borrelia sp. IgM is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. 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.
38594036043016KZ-301-12(01)38594036043016
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105010604LYME ANTIBODY IGM10 warnings recorded — scroll inside the panel to see all entries.
CZ-MF-000036964No 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.OTHER
Primary placement in Czechia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
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.
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-18594036047010On the marketMONO-VIDITEST anti-Borrelia sp. IgG + VIsEB-38594036043009On the marketMONO-VIDITEST anti-Borrelia sp. IgG + VIsEB-18594036043005On the marketMONO-VIDITEST anti-Borrelia sp. IgMB-18594036043012On the marketMONO-VIDITEST anti-Chlamydia pneumonieae IgAB-38594036042323On the marketMONO-VIDITEST anti-Chlamydia pneumonieae IgAB-18594036042329On the market