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Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)

by Sansure Biotech Inc. FDA registration: China EUDAMED

Ref S3310E-24 EMDN W0105070201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69557927S3310E000001NG Basic UDI-DIDate18 Apr 2025RegisteredStatusActive
European UnionCE/IVDD Number69557927S3310E000001NG Basic UDI-DIDate18 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
S3310E-24
Primary DI / UDI-DI
06955792701069, 06955792731264
Basic UDI-DI
69557927S3310E000001NG, B-06955792731264
EMDN Code
W0105070201 Gram+ - gram- - fungi - multiplex na reagents
Device Class
Class C
Class IVD General
Market of Registration
France

Manufacturer details

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

Other devices from Sansure Biotech Inc.

See all devices from Sansure Biotech Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 0c9c2456-95cc-4a07-8378-6f883e9ba725 61 fields · synced 24 Oct 2026
  • EUDAMED 06955792731264|B-06955792731264 61 fields · synced 19 May 2026