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EUDAMED last updated this device on May 21, 2026
697431271001H2Automatic nucleic acid extractor is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Changsha Imadek Intelligent Technology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974312710824697431271001H2SMART-4000(01)06974312710824
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.
W02069099VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW011No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | May 21, 2026 | May 21, 2066 |
| EL | May 21, 2026 | May 21, 2066 |
| Spain | May 21, 2026 | May 21, 2066 |
| France | May 21, 2026 | May 21, 2066 |
| Italy | May 21, 2026 | May 21, 2066 |
CN-MF-000042852No 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.