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Silicone CPAP Mask

by Xiamen Compower Medical Tech. Co., Ltd. 9 variants

Ref SCM0101002Model FL-01, FM-01, FS-01

Active European Union

CE MDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694643043723402Q8 Basic UDI-DI Date13 Jun 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
FL-01, FM-01, FS-01, SCM0101002
Primary DI / UDI-DI
06946430419606, 06946430426017
Basic UDI-DI
694643043723402Q8
Direct Marketing DI
06946430419606
06946430426017
EMDN Code
R0301010201 Cpap masks
Device Class
Class IIa
EU market of registration
Italy
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000011703
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Xiamen Compower Medical Tech. Co., Ltd.

See all devices from Xiamen Compower Medical Tech. Co., Ltd. →

Properties

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