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PowerPrep™ Whole blood NA Extraction Kit EXP

by KogeneBiotech Co., Ltd. 2 variants

Ref E0018S

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88000563E00185F Basic UDI-DI 08800056300053UDI-DIDate2 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
E0018S
Primary DI / UDI-DI
08800056300053
Basic UDI-DI
88000563E00185F
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
KR-MF-000045858
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Other devices from KogeneBiotech Co., Ltd.

See all devices from KogeneBiotech Co., Ltd. →

Properties

  • 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