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EUDAMED last updated this device on May 26, 2026
697597065023QJcfDNA Isolation Kit (Magnetic Beads) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by SINGLERA GENOMICS (JIANGSU) LTD.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06975970650088697597065023QJEP120192CE(01)06975970650088
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.
W01019099CLINICAL CHEMISTRY REAGENTS - OTHERNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Still on market |
CN-MF-000033428No 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.697597065022QGOn the marketBisulfite Conversion Kit (Spin Column)697597065022QGOn the marketcfDNA Isolation Kit (Magnetic Beads)697597065023QJOn the marketMulti-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence Probing)B-06975970650033On the marketNucleic Acid Purification System697597065INST04ZNOn the market