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eazyOne molecular detection device

by Winnoz Technology, Inc. EUDAMED

Active European Union

Ref DD-V-B001Model ED-001; ED-V-B001

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471988964ED-001C2 Basic UDI-DIDate18 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

Device Name
"eGGi" Molecular Detection System; eazyOne molecular detection system
Model / Reference
ED-001, ED-V-B001, DD-V-B001
Primary DI / UDI-DI
04719889640080
Basic UDI-DI
471988964ED-001C2
EMDN Code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000036356
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Reagent
  • Professional Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No