- Role
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- Date of registration
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EUDAMED last updated this device on May 22, 2026
PP138061491600125Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Sample Collection Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by genEplanet, osebna genetika, d.o.o.. Placed on the EU market in Slovenia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →1313806NCKX101N049Basic 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 →PP138061491600125NCKX101NUDI 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 →1313806NCKX101N049
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0501010199VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHERSterile
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 →No certificate specifically references this device's Basic UDI-DI.
This device is not currently linked to any other device.
Primary placement in Slovenia; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| SloveniaPrimary placement | Still on market | |
| Austria | Still on market | |
| Czechia | Still on market | |
| Spain | Still on market | |
| Croatia | Still on market | |
| Hungary | Still on market | |
| Italy | Still on market | |
| Latvia | Still on market | |
| Romania | Still on market | |
| Slovakia | Still on market |
SI-MF-000021254No 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.