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CPAP Mask Liners

by RespiraSource, OPC Philippines EUDAMED

Ref CHMLN

EMDN Z12030102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850040313ML6S Basic UDI-DIDate15 Jun 2025RegisteredStatusUnknown

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Status not known
  • Not covered

European Union — CE/MDR Status not known

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CHMLN
Primary DI / UDI-DI
00850030671417
Basic UDI-DI
0850040313ML6S
EMDN Code
Z12030102 Continuous positive pressure equipment
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
PH-MF-000013799
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from RespiraSource, OPC

See all devices from RespiraSource, OPC →

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 1b5ebb6c-22bd-4540-bbda-a0919bc0a2ee 61 fields · synced 22 Oct 2026