Skip to content

Sample Release Reagent

by Sansure Biotech Inc. EUDAMED

Active European Union

Ref S1015E-24

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69557927S1015E000001LS Basic UDI-DIDate16 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • 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  • Withdrawn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
S1015E-24
Primary DI / UDI-DI
06955792713529
Basic UDI-DI
69557927S1015E000001LS
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000011392
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Other devices from Sansure Biotech Inc.

See all devices from Sansure Biotech Inc. →

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