Cell Nucleic Acid Extraction Kit (Magnetic Bead Method)

by Jiangsu Bioperfectus Technologies Co., Ltd. EUDAMED

Active European Union

Ref SDK80125A-96T

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Withdrawn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: SDK80125A-96T

Primary DI / UDI-DI: 06973342006020
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

Other devices from Jiangsu Bioperfectus Technologies Co., Ltd.

Cell Nucleic Acid Extraction Kit (Magnetic Bead Method)

Class A
Nucleic Acid Extraction Rapid Kit 96T (Magnetic Bead Method)

Class A
Genetic-Specific Whole Blood DNA Extraction Kit (Magnetic Bead Method)

Class A
Specimen collection preservation tube (Salmonella and Shigella enrichment type)

Class A
Sputum DNA Isolation Kit (Boiling Method)

Class A
Automated Pipetting System

Class A

See all devices from Jiangsu Bioperfectus Technologies Co., Ltd. →

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