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AcfS Software

by Roche Molecular Systems, Inc.

Ref 07831773001

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number761333603580BB Basic UDI-DI 07613336155905UDI-DIDate25 Sep 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Ariosa® cell-free DNA System (AcfS) Software
Model / Reference
07831773001
Primary DI / UDI-DI
07613336155905
Basic UDI-DI
761333603580BB
EMDN Code
W0106010306 Multiple detection of chromosomal disorders tests
Device Class
Class C
Special Device Type
Software
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018066
Authorised representative
Roche Diagnostics GmbH DE-AR-000006262

Other devices from Roche Molecular System, Inc.

See all devices from Roche Molecular System, Inc. →

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