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Mag-Bind® cfDNA Kit CE IVD

by Omega Bio-tek 2 variants

Ref M3298-02CEIVDModel M3298-01CEIVD

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081009790M3298CEIVDHZ Basic UDI-DI 00810097902121UDI-DIDate23 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
M3298-01CEIVD, M3298-02CEIVD
Primary DI / UDI-DI
00810097902121
Basic UDI-DI
081009790M3298CEIVDHZ
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000024148
Authorised representative
QbD RepS BV BE-AR-000000040

From the manufacturer

Manufacturer's product page: Pre-filled Mag-Bind® Kits

Other devices from Omega Bio-tek

See all devices from Omega Bio-tek →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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