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Concentriq AP-Dx

by Proscia, Inc. 3 variants

Ref DX050GLModel Concentriq AP-Dx

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 Number0860006054526R7 Basic UDI-DI 00850070164016UDI-DIDate16 Mar 2023RegisteredStatusActive

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  • Withdrawn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
Concentriq AP-Dx, DX050GL
Primary DI / UDI-DI
00850070164016
Basic UDI-DI
0860006054526R7
Direct Marketing DI
00850070164016
EMDN Code
W02079092 Various general purpose IVD instruments - IVD medical device software
Device Class
Class A
Special Device Type
Software
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
US-MF-000027154
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Proscia, Inc.

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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