- Role
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- Date of registration
- Address
US-MF-000031517QBC Capillary Centrifuge is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. 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 Oct 26, 2023
0858092006DDCCXZPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00858092006031
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
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 | Feb 1, 2007 | Still on market |
| Austria | Feb 1, 2007 | Still on market |
| Belgium | Feb 1, 2007 | Still on market |
| Bulgaria | Feb 1, 2007 | Still on market |
| Cyprus | Feb 1, 2007 | Still on market |
| Czechia | Feb 1, 2007 | Still on market |
| Germany | Feb 1, 2007 | Still on market |
| Denmark | Feb 1, 2007 | Still on market |
| Estonia | Feb 1, 2007 | Still on market |
| EL | Feb 1, 2007 | Still on market |
| Spain | Feb 1, 2007 | Still on market |
| Finland | Feb 1, 2007 | Still on market |
| France | Feb 1, 2007 | Still on market |
| Croatia | Feb 1, 2007 | Still on market |
| Hungary | Feb 1, 2007 | Still on market |
| Ireland | Feb 1, 2007 | Still on market |
| Iceland | Feb 1, 2007 | Still on market |
| Italy | Feb 1, 2007 | Still on market |
| Liechtenstein | Feb 1, 2007 | Still on market |
| Lithuania | Feb 1, 2007 | Still on market |
| Luxembourg | Feb 1, 2007 | Still on market |
| Latvia | Feb 1, 2007 | Still on market |
| Malta | Feb 1, 2007 | Still on market |
| Netherlands | Feb 1, 2007 | Still on market |
| Norway | Feb 1, 2007 | Still on market |
| Poland | Feb 1, 2007 | Still on market |
| Portugal | Feb 1, 2007 | Still on market |
| Romania | Feb 1, 2007 | Still on market |
| Sweden | Feb 1, 2007 | Still on market |
| Slovenia | Feb 1, 2007 | Still on market |
| Slovakia | Feb 1, 2007 | Still on market |
| Türkiye | Feb 1, 2007 | 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.
00858092006031Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
0858092006DDCCXZ425740UDI 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.
W02069003CENTRIFUGES0858092006DDATYVOn the marketQBC Capillary Blood Tube, 100 Test Kit0858092006DDCTZ3On the marketQBC Capillary Blood Tube, 1000 Test Kit0858092006DDCTZ3On the marketQBC Capillary Centrifuge, Refurbished0858092006DDCCXZOn the marketQBC STAR Tube, 100 Test Kit0858092006DDST2NOn the marketQBC STAR Tube, 20 Test Kit0858092006DDST2NOn the marketNo 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.