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Fitsit Evo

by Ledragomma S.R.L. EUDAMED

Active European Union

Ref 3301Model Cuscini posturali

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8006531FT03UZ Basic UDI-DIDate14 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
Cuscini posturali
Model / Reference
Cuscini posturali, 3301
Primary DI / UDI-DI
08006531800296
Basic UDI-DI
8006531FT03UZ
EMDN Code
V0899 Medical support equipment - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IT-MF-000018764

Other devices from Ledragomma S.R.L.

See all devices from Ledragomma S.R.L. →

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