Nucleic Acid Extraction Kit

by Jiangsu Mole Bioscience Co., LTD. China EUDAMED

Ref PL08812T2064 EMDN W0105900101

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697089547NAEK00R2 Basic UDI-DI	Date26 Oct 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name: Nucleic Acid Extraction Kit
Model / Reference: PL08812T2064

Primary DI / UDI-DI: 06970895473262
Basic UDI-DI: 697089547NAEK00R2
EMDN Code: W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus

Device Class: Class A
Market of Registration: Czechia

Manufacturer details

EUDAMED SRN: CN-MF-000001539
Authorised representative: Lotus NL B.V. NL-AR-000000121

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (9)

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

Sources (1)

EUDAMED 06970895473262|697089547NAEK00R2 61 fields · synced 23 Oct 2026