- Role
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EUDAMED last updated this device on May 28, 2026
697334200SDK60120KGPathogen DNA/RNA Extraction Kit (Magnetic Bead Method) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Jiangsu Bioperfectus Technologies Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CN-MF-000014691(01)06973342006303
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | 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.
06973342006303Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
697334200SDK60120KG SDK60120-48T(8*6)UDI 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.
W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.697334200SDK80125LGOn the marketCell Nucleic Acid Extraction Kit (Magnetic Bead Method)697334200SDK80125LGOn the marketPathogen DNA/RNA Extraction Kit (Magnetic Bead Method)697334200SDK60120KGOn the marketPathogen DNA/RNA Extraction Kit (Magnetic Bead Method)697334200SDK60120KGOn the marketSpecimen collection preservation tube (Salmonella and Shigella enrichment type)697334200JC800042MOn the marketSpecimen collection preservation tube (Salmonella and Shigella enrichment type)697334200JC800042MOn the marketNo certificate specifically references this device's Basic UDI-DI.