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EUDAMED last updated this device on Jun 22, 2026
B-09309001216023InfectID-Client Software is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Microbio Ltd. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
AU-MF-000033903(01)09309001216023
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Refer to software user guide and IFU
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 Czechia; available across 9 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Jun 5, 2025 | Dec 31, 2028 |
| Denmark | Sep 25, 2025 | Dec 31, 2028 |
| EL | Sep 11, 2024 | Dec 31, 2028 |
| Spain | Apr 1, 2025 | Dec 31, 2028 |
| Italy | Sep 9, 2024 | Dec 31, 2028 |
| Netherlands | May 3, 2022 | Dec 31, 2028 |
| Portugal | Oct 18, 2024 | Dec 31, 2028 |
| Romania | Sep 11, 2024 | Dec 31, 2028 |
| Slovakia | Jun 5, 2025 | Dec 31, 2028 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
09309001216023Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-09309001216023V1.1UDI 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.
W02050192NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWAREPrimary 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.
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.