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CPAP Face Mask

by Hsiner Co., Ltd. EUDAMED

Active European Union

Ref 12643

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04719964250654 Basic UDI-DIDate5 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

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.

Specification

EUDAMED

Device Name
CPAP Face Mask
Model / Reference
12643
Primary DI / UDI-DI
04719964250654
Basic UDI-DI
B-04719964250654
EMDN Code
R0301010201 Cpap masks
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
TW-MF-000007258
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Hsiner Co., Ltd.

See all devices from Hsiner Co., Ltd. →

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