Skip to content

Stimulateur Flowtens

by Flowstim Technology France EUDAMED

Ref FLO-02-201Model STIMULATEUR FLOWTENS

EMDN Z12062780

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberZ-22-160-S-IX-E Date15 Apr 2026IssuedStatusActive expires 31 Jul 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • Z-22-160-S-IX-E Issued

    Quality management system EU MDR

    Notified body
    Notified body 0633
    Issued
    15 Apr 2026
    Expires
    31 Jul 2027

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
STIMULATEUR FLOWTENS, FLO-02-201
Primary DI / UDI-DI
03770025687049
Basic UDI-DI
3770025687FLO-02-201ZR
Direct Marketing DI
03770025687049
EMDN Code
Z12062780 Functional electrical stimulation systems - hardware accessories
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000018490

Other devices from Flowstim Technology

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED d44bcedc-486c-4984-9f8d-d5e91ae758b3 61 fields · synced 22 Oct 2026