Cell Nucleic Acid Extraction Kit (Magnetic Bead Method)

by Jiangsu Bioperfectus Technologies Co., Ltd. EUDAMED

Active European Union

Ref SDK80125V

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697334200SDK80125LG Basic UDI-DI	Date7 May 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference: SDK80125V

Primary DI / UDI-DI: 06973342006280
Basic UDI-DI: 697334200SDK80125LG
EMDN Code: W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus

Device Class: Class A
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000014691
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

Reagent

Other properties (10)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Professional Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No