- Organization name
- UDI-DI code
- Reference / catalog number
AT-MF-000024115Technoplastin HIS is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Aug 11, 2026
912003686TC6T00000019NPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)09120036860094
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Austria; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | Jun 30, 2026 | Still on market |
| Belgium | Jun 30, 2026 | Still on market |
| Bulgaria | Jun 30, 2026 | Still on market |
| Cyprus | Jun 30, 2026 | Still on market |
| Czechia | Jun 30, 2026 | Still on market |
| Germany | Jun 30, 2026 | Still on market |
| Denmark | Jun 30, 2026 | Still on market |
| Estonia | Jun 30, 2026 | Still on market |
| EL | Jun 30, 2026 | Still on market |
| Spain | Jun 30, 2026 | Still on market |
| Finland | Jun 30, 2026 | Still on market |
| France | Jun 30, 2026 | Still on market |
| Croatia | Jun 30, 2026 | Still on market |
| Hungary | Jun 30, 2026 | Still on market |
| Ireland | Jun 30, 2026 | Still on market |
| Iceland | Jun 30, 2026 | Still on market |
| Italy | Jun 30, 2026 | Still on market |
| Liechtenstein | Jun 30, 2026 | Still on market |
| Lithuania | Jun 30, 2026 | Still on market |
| Luxembourg | Jun 30, 2026 | Still on market |
| Latvia | Jun 30, 2026 | Still on market |
| Malta | Jun 30, 2026 | Still on market |
| Netherlands | Jun 30, 2026 | Still on market |
| Norway | Jun 30, 2026 | Still on market |
| Poland | Jun 30, 2026 | Still on market |
| Portugal | Jun 30, 2026 | Still on market |
| Romania | Jun 30, 2026 | Still on market |
| Sweden | Jun 30, 2026 | Still on market |
| Slovenia | Jun 30, 2026 | Still on market |
| Slovakia | Jun 30, 2026 | Still on market |
| Türkiye | Jun 30, 2026 | Still on market |
| XI | Jun 30, 2026 | 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.
09120036860094Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
912003686TC6T00000019N5003030UDI 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.
W0103020101PROTHROMBIN TIME ( QUICK TEST )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.912003686TCFB00000019ROn the marketTechnoplastin HIS912003686TC6T00000019NOn the marketTechnoplastin HIS912003686TC6T00000019NOn the marketTechnoplastin HIS912003686TC6T00000019NOn the marketTechnoplastin HIS Ceveron912003686TC6T00000029QOn the marketTechnoplastin HIS Ceveron912003686TC6T00000029QOn the marketNo certificate specifically references this device's Basic UDI-DI.