- Role
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US-MF-00003151742900109 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Drucker Diagnostics. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Feb 4, 2025
B-00858092006055Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00858092006055
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 XI; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| XIPrimary placement | May 1, 2013 | Still on market |
| Austria | May 1, 2013 | Still on market |
| Belgium | May 1, 2013 | Still on market |
| Bulgaria | May 1, 2013 | Still on market |
| Cyprus | May 1, 2013 | Still on market |
| Czechia | May 1, 2013 | Still on market |
| Germany | May 1, 2013 | Still on market |
| Denmark | May 1, 2013 | Still on market |
| Estonia | May 1, 2013 | Still on market |
| EL | May 1, 2013 | Still on market |
| Spain | May 1, 2013 | Still on market |
| Finland | May 1, 2013 | Still on market |
| France | May 1, 2013 | Still on market |
| Croatia | May 1, 2013 | Still on market |
| Hungary | May 1, 2013 | Still on market |
| Ireland | May 1, 2013 | Still on market |
| Iceland | May 1, 2013 | Still on market |
| Italy | May 1, 2013 | Still on market |
| Liechtenstein | May 1, 2013 | Still on market |
| Lithuania | May 1, 2013 | Still on market |
| Luxembourg | May 1, 2013 | Still on market |
| Latvia | May 1, 2013 | Still on market |
| Malta | May 1, 2013 | Still on market |
| Netherlands | May 1, 2013 | Still on market |
| Norway | May 1, 2013 | Still on market |
| Poland | May 1, 2013 | Still on market |
| Portugal | May 1, 2013 | Still on market |
| Romania | May 1, 2013 | Still on market |
| Sweden | May 1, 2013 | Still on market |
| Slovenia | May 1, 2013 | Still on market |
| Slovakia | May 1, 2013 | Still on market |
| Türkiye | May 1, 2013 | 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.
00858092006055Basic 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-0085809200605542900109UDI 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.
W0202010101AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)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.