Skip to content

Epstein-Barr Virus Detection Kit (Fluorescence PCR)

by Healgen Scientific Limited Liability Company United States EUDAMED

Ref AEBV01-AHG48E; AEBV01D-AHG48E

EMDN W0105040403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-81649002AEBV01BNGJ Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Epstein-Barr Virus Detection Kit (Fluorescence PCR)
Model / Reference
AEBV01-AHG48E, AEBV01D-AHG48E
Primary DI / UDI-DI
D-81649002AEBV01BNGJ
Basic UDI-DI
B-81649002AEBV01BNGJ
EMDN Code
W0105040403 Ebv - na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healgen Scientific Limited Liability Company

See all devices from Healgen Scientific Limited Liability Company →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 29fb7f8d-42be-45d5-9724-3a78ba82898a-1 61 fields · synced 22 Oct 2026