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AFCS SANDS (SAT1) Bed unit

by Synergie Nederland EUDAMED

Active European Union

Ref 1010403Model SAT

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8720387388SATGQ Basic UDI-DIDate17 Mar 2025RegisteredStatusActive

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  • Withdrawn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)
  • 2259705CE01 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    5 Nov 2024
    Expires
    1 Nov 2029

Specification

EUDAMED

Device Name
Air Fluidised Care System
Model / Reference
SAT, 1010403
Primary DI / UDI-DI
08720387388387
Basic UDI-DI
8720387388SATGQ
Direct Marketing DI
08720387388387
EMDN Code
V08060199 Electric medical beds - other
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000013839

Other devices from Synergie Nederland

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