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Viral Nucleic Acid Extraction Kit (Spin Column)

by Zhejiang Orient Gene Biotech Co., Ltd EUDAMED

Active European Union

Ref SNCE07-AOG50E

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69509960SNCE07XHBY Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Viral Nucleic Acid Extraction Kit (Spin Column)
Model / Reference
SNCE07-AOG50E
Primary DI / UDI-DI
D-69509960SNCE07XHBY
Basic UDI-DI
B-69509960SNCE07XHBY
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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