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by Alcediag

Ref 0100

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 NumberB-FR-MF-0000249264W Basic UDI-DI Date24 Jun 2025RegisteredStatusActive
European UnionCE/IVDD NumberB-FR-MF-0000249264W Basic UDI-DI Date24 Jun 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Model / Reference
0100
Primary DI / UDI-DI
D-FR-MF-0000249264W, 37700434710196
Basic UDI-DI
B-FR-MF-0000249264W, 37700434710100KS
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
Class C
Special Device Type
-1202
Software
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000024926

Properties

  • 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