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CPAP Mask Liners

by RespiraSource, OPC Philippines EUDAMED

Ref B0CNWL4MF7, B0B4BMGR5J, B092JPRHYM, B0B4BLC27Y, B092JSVV4V, B092JQZQQB, B07MT4CDMG, B09QRVMJCK, B092JQ1FMK

EMDN Z12030102

Regulatory status

as of 25 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

Model / Reference
B0CNWL4MF7, B0B4BMGR5J, B092JPRHYM, B0B4BLC27Y, B092JSVV4V, B092JQZQQB, B07MT4CDMG, B09QRVMJCK, B092JQ1FMK
Primary DI / UDI-DI
00850038100520, 00850040313253, 00850030671080, 00850040313246, 00850030671073, 00850030671066, 00850038100827, 00850038100155, 00850030671097
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 (9)

  • EUDAMED 57e982ea-613c-492e-9e61-d8a0b253764e 61 fields · synced 24 Oct 2026
  • EUDAMED 00850040313253|0850040313ML6S 61 fields · synced 11 May 2026
  • EUDAMED 00850030671080|0850040313ML6S 61 fields · synced 16 May 2026
  • EUDAMED 00850040313246|0850040313ML6S 61 fields · synced 17 May 2026
  • EUDAMED 00850030671073|0850040313ML6S 61 fields · synced 17 May 2026
  • EUDAMED 00850030671066|0850040313ML6S 61 fields · synced 17 May 2026
  • EUDAMED 00850038100827|0850040313ML6S 61 fields · synced 18 May 2026
  • EUDAMED 00850038100155|0850040313ML6S 61 fields · synced 18 May 2026
  • EUDAMED 00850030671097|0850040313ML6S 61 fields · synced 19 May 2026