Cell Nucleic Acid Extraction Kit (Magnetic Bead Method)

by Jiangsu Bioperfectus Technologies Co., Ltd. EUDAMED

Active European Union

Ref SDK80125R-48T

Regulatory status

as of 29 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Withdrawn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 covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference: SDK80125R-48T

Primary DI / UDI-DI: 06973342004613
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