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Masker

by Praesidia S.r.l. Italy EUDAMED

Ref 38002Model MaskerOne

EMDN Z12011285

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803367578MASKMASKERONETA Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
MaskerOne
Model / Reference
MaskerOne, 38002
Primary DI / UDI-DI
08033675780610
Basic UDI-DI
803367578MASKMASKERONETA
EMDN Code
Z12011285 Patient positioning instruments - consumables
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000010975

Other devices from Praesidia S.r.l.

See all devices from Praesidia S.r.l. →

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 (1)

  • EUDAMED 712fd6aa-9204-496a-a851-a9199968d2ce 61 fields · synced 22 Oct 2026