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Anti Decubitus Mattress

by Shenzhen Fitconn Technology Co., ltd EUDAMED

Active European Union

Ref FU-AM001LModel FU-AM001, FU-AM002, FU-AM003, FU-AM001L

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberFI26/1008022 Date1 Jul 2026IssuedStatusActive expires 16 Apr 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI26/1008022 Supplemented

    Quality management system EU MDR

    Notified body
    SGS FIMKO OY 0598
    Issued
    1 Jul 2026
    Expires
    16 Apr 2031
    Reason
    Other

Specification

EUDAMED

Model / Reference
FU-AM001, FU-AM002, FU-AM003, FU-AM001L
Primary DI / UDI-DI
06970470486014
Basic UDI-DI
697047048FUADMKH
Direct Marketing DI
06970470486014
EMDN Code
V080701 Active anti-decubitus medical mattresses
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000024538
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen Fitconn Technology Co., ltd

See all devices from Shenzhen Fitconn Technology Co., ltd →

Properties

Show 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