- Role
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- Date of registration
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EUDAMED last updated this device on May 25, 2026
0195226001204PZPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →HemosIL CL HIT-IgG(PF4-H) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Instrumentation Laboratory Company. Placed on the EU market in Italy. 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 →00195226001204Basic 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 →0195226001204PZ0029706200UDI 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 →(01)00195226001204
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103020402PLATELET FACTOR 4Sterile
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.
Primary placement in Italy; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | May 25, 2026 | Still on market |
| Austria | May 25, 2026 | Still on market |
| Belgium | May 25, 2026 | Still on market |
| Bulgaria | May 25, 2026 | Still on market |
| Cyprus | May 25, 2026 | Still on market |
| Czechia | May 25, 2026 | Still on market |
| Germany | May 25, 2026 | Still on market |
| Denmark | May 25, 2026 | Still on market |
| Estonia | May 25, 2026 | Still on market |
| EL | May 25, 2026 | Still on market |
| Spain | May 25, 2026 | Still on market |
| Finland | May 25, 2026 | Still on market |
| France | May 25, 2026 | Still on market |
| Croatia | May 25, 2026 | Still on market |
| Hungary | May 25, 2026 | Still on market |
| Ireland | May 25, 2026 | Still on market |
| Iceland | May 25, 2026 | Still on market |
| Liechtenstein | May 25, 2026 | Still on market |
| Lithuania | May 25, 2026 | Still on market |
| Luxembourg | May 25, 2026 | Still on market |
| Latvia | May 25, 2026 | Still on market |
| Malta | May 25, 2026 | Still on market |
| Netherlands | May 25, 2026 | Still on market |
| Norway | May 25, 2026 | Still on market |
| Poland | May 25, 2026 | Still on market |
| Portugal | May 25, 2026 | Still on market |
| Romania | May 25, 2026 | Still on market |
| Sweden | May 25, 2026 | Still on market |
| Slovenia | May 25, 2026 | Still on market |
| Slovakia | May 25, 2026 | Still on market |
| Türkiye | May 25, 2026 | Still on market |
| XI | May 25, 2026 | Still on market |
US-MF-000035586No 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.