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Profle for Pelfix Mask Left

by MacroMedics Netherlands EUDAMED

Ref 133210L EMDN Z12011280

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number872016816117000HP Basic UDI-DIDate2 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Thermoplastic Mask
Model / Reference
133210L
Primary DI / UDI-DI
08719425709512
Basic UDI-DI
872016816117000HP
EMDN Code
Z12011280 Patient positioning instruments - hardware accessories
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000006068

Other devices from Macromedics BV

See all devices from Macromedics BV →

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 35eec6b3-19ba-48dc-aed8-99b6db1793ee 61 fields · synced 25 Oct 2026