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Helix Elite™ QC Sets and Panels

by Microbiologics, INC. United States EUDAMED

Ref [8257] Helix Elite™ QC Sets and Panels Helix Elite™ Comprehensive Human Papillomavirus (HPV) Control PanelModel 8257

EMDN W0105080801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number084535708257BK Basic UDI-DIDate9 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Helix Elite™ QC Sets and Panels
Model / Reference
8257, [8257] Helix Elite™ QC Sets and Panels Helix Elite™ Comprehensive Human Papillomavirus (HPV) Control Panel
Primary DI / UDI-DI
70845357044517
Basic UDI-DI
084535708257BK
EMDN Code
W0105080801 Bacteriology controls - inf.imm.
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000000466
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Other devices from Microbiologics, Inc.

See all devices from Microbiologics, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 2b835214-1682-4492-9bdf-72557613484a 61 fields · synced 24 Oct 2026