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Ebola Virus Nucleic Acid Detection Kit

by Hangzhou Immuno Biotech Co., Ltd China EUDAMED

Ref PEB001 EMDN W0105040627

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974238911213 Basic UDI-DIDate22 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Ebola Virus Nucleic Acid Detection Kit (Lyophilized Fluorescent PCR Method)
Model / Reference
PEB001
Primary DI / UDI-DI
06974238911213
Basic UDI-DI
B-06974238911213
EMDN Code
W0105040627 Ebola (filovirus)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000001118
Authorised representative
Immuno International BV NL-AR-000043887

Other devices from Hangzhou Immuno Biotech Co., Ltd

See all devices from Hangzhou Immuno Biotech Co., Ltd →

Properties & raw data

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

Sources (1)

  • EUDAMED 06974238911213|B-06974238911213 61 fields · synced 25 Oct 2026