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MERLIN Diagnostic Workcenter

by Phönix-PACS GmbH 3 variants

Ref 5.8.1

Active European Union

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-1311643DW05821 Basic UDI-DI 1311643DW05821UDI-DIDate28 Jan 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
MERLIN Diagnostic Workcenter
Model / Reference
5.8.1
Primary DI / UDI-DI
1311643DW05821
Basic UDI-DI
B-1311643DW05821
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
Device Class
Class I
Special Device Type
-1192
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005785

Other devices from Phönix-PACS GmbH

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No