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Kalli Hr

by Winncare France EUDAMED

Active European Union

Ref 04.234, 04.294B, 04.294, 04.235B, 04.297, 04.236, 04.299PX, D04.234PX, 04.237PX, 04.234PX, 04.297B, D04.295PX, 04.299, D04.236PX, 04.299BModel CHR

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number366489702654JE Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Coussins KALLI HR, KALLI DOS HR
Model / Reference
CHR, 04.234, 04.294B, 04.294, 04.235B, 04.297, 04.236, 04.299PX, D04.234PX, 04.237PX, 04.234PX, 04.297B, D04.295PX, 04.299, D04.236PX, 04.299B
Primary DI / UDI-DI
03664604041172, 03664604058033, 03664604041141, 03664604058057, 03664604041127, 03664604041158, 03664604013575, 03664604013957, 03664604020009, 03664604013230, 03664604058019, 03664604007222, 03664604041110, 03664604003880, 03664604058002
Basic UDI-DI
366489702654JE
EMDN Code
V080399 Medical cushions - other
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000482

Other devices from Winncare France

See all devices from Winncare France →

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