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Mask SSPS™-FSONN

by MacroMedics Netherlands EUDAMED

Ref 115740M

EMDN Z12011285

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number872016816112100GR Basic UDI-DIDate2 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
DSPS & SSPS cradle and mask
Model / Reference
115740M
Primary DI / UDI-DI
08720168160119
Basic UDI-DI
872016816112100GR
EMDN Code
Z12011285 Patient positioning instruments - consumables
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000006068

Other devices from Macromedics BV

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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 549f7c54-8014-43a9-bd65-d3d0e2a943b4 61 fields · synced 25 Oct 2026