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FitMax® CPAP Total Face Mask

by Besmed Health Business Corp. Taiwan EUDAMED

Ref CA-63625 EMDN R0301010201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04716770636252 Basic UDI-DIDate10 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
FitMax Reusable CPAP Total Face Mask with Standard Elbow, Anti-Asphyxia Elbow, Size XL
Model / Reference
CA-63625
Primary DI / UDI-DI
04716770636252
Basic UDI-DI
B-04716770636252
EMDN Code
R0301010201 Cpap masks
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
TW-MF-000007246
Authorised representative
Casus Europe B.V. NL-AR-000037688

Other devices from Besmed Health Business Corp.

See all devices from Besmed Health Business Corp. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 03be5b9a-e15d-45e6-ad45-07b0636997aa 61 fields · synced 22 Oct 2026