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Comfort Cushion Cover

by The Comfort Companies, LLC 768 variants

Ref CU-FRS-18W19D-CV

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, self-declared

Class I: no certifier involved

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/MDR Number0194637MCCAZ Basic UDI-DI 00194637031510UDI-DIDate6 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Medical Cushion Cover
Model / Reference
CU-FRS-18W19D-CV
Primary DI / UDI-DI
00194637031510
Basic UDI-DI
0194637MCCAZ
EMDN Code
V080399 Medical cushions - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000032945
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from The Comfort Companies, LLC

See all devices from The Comfort Companies, LLC →

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