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FitMax CPAP Total face mask

by Besmed Health Business Corp. 5 variants

Ref CA-63603, CA-63600, CA-63608, CA-63609, CA-63602, CA-63606

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-CA-63603P8 Basic UDI-DI Date29 Mar 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
FitMax CPAP Total face mask with Standard Elbow and corrugate tube, size XS
FitMax CPAP Total face mask with Standard Elbow, size M
FitMax CPAP Total face mask with Anti-Asphyxia Elbow, size XL
FitMax CPAP Total face mask with Anti-Asphyxia Elbow and corrugate tube, size S
FitMax CPAP Total face mask with Standard Elbow, size L
FitMax CPAP Total face mask with Standard Elbow, size XL
Model / Reference
CA-63603, CA-63600, CA-63608, CA-63609, CA-63602, CA-63606
Primary DI / UDI-DI
D-CA-63603P8, D-CA-63600P2, D-CA-63608PJ, D-CA-63609PL, D-CA-63602P6, D-CA-63606PE
Basic UDI-DI
B-CA-63603P8, B-CA-63600P2, B-CA-63608PJ, B-CA-63609PL, B-CA-63602P6, B-CA-63606PE
EMDN Code
R0301010201 Cpap masks
Device Class
Class IIa
EU market of registration
Türkiye

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

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