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Dds/Fix

by Fondazione Centro Nazionale Di Adroterapia Oncologica Italy EUDAMED

Ref DDS/FIX 003, DDS/FIX 004, DDS/FIX 002Model DDS/FIX

EMDN Z11019099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCVP0001220225 Date1 Apr 2025IssuedStatusActive expires 3 Aug 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

5 certificates · EUDAMED

EUDAMED certificates (5)
  • CVP0001220225 Amended

    Product verification EU MDR

    Issued
    1 Apr 2025
    Expires
    3 Aug 2027
    Reason
    Other
  • CVP0002220225 Amended

    Product verification EU MDR

    Issued
    1 Apr 2025
    Expires
    3 Aug 2027
    Reason
    Other
  • CVP0003220225 Amended

    Product verification EU MDR

    Issued
    1 Apr 2025
    Expires
    3 Aug 2027
    Reason
    Other
  • CVP0004220225 Amended

    Product verification EU MDR

    Issued
    1 Apr 2025
    Expires
    3 Aug 2027
    Reason
    Other
  • CVT000122 Amended

    Type examination EU MDR

    Issued
    12 Jul 2023
    Expires
    3 Aug 2027
    Reason
    Mnf data change

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Dds/Fix
Model / Reference
DDS/FIX, DDS/FIX 003, DDS/FIX 004, DDS/FIX 002
Primary DI / UDI-DI
08054154660032, 08054154660049, 08054154660018, 08054154660025
Basic UDI-DI
805415466_DDS/FIX_K7
EMDN Code
Z11019099 Various radiotherapy and radiosurgery instruments - other
Device Class
Class IIb
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
IT-MF-000021295

Other devices from Fondazione Centro Nazionale Di Adroterapia Oncologica

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (4)

  • EUDAMED 4e6b52af-9127-4283-8ee7-5760e884044b 61 fields · synced 22 Oct 2026
  • EUDAMED 08054154660049|805415466_DDS/FIX_K7 61 fields · synced 17 May 2026
  • EUDAMED 08054154660018|805415466_DDS/FIX_K7 61 fields · synced 18 May 2026
  • EUDAMED 08054154660025|805415466_DDS/FIX_K7 61 fields · synced 18 May 2026