Skip to content

CPAP Mask Wipes

by RespiraSource, OPC Philippines EUDAMED

Ref CHMLFF

EMDN Z12030102

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
CPAP Mask Liners
Model / Reference
CHMLFF
Primary DI / UDI-DI
00850011958704
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 03aca044-f374-41f2-a164-8e96457ce99c 61 fields · synced 24 Oct 2026