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MosaiQ® AiPlex CTDplus

by AliveDx Suisse SA 3 variants

Ref 160009Model 1x250, 4x85, 1x85

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number764032746CTDPLUSMAGH5 Basic UDI-DI 07640327462308UDI-DIDate18 Feb 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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
1x250, 4x85, 1x85, 160009
Primary DI / UDI-DI
07640327462308
Basic UDI-DI
764032746CTDPLUSMAGH5
Direct Marketing DI
07640327462308
EMDN Code
W0102100199 Autoimmune connective tissue diseases testing - other
Device Class
Class B
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CH-MF-000024025
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No