Skip to content

Adverse events

by Synapse medicine France EUDAMED

Ref Effets indésirables, Adverse Events

EMDN Z12040292

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37016244EfIndesirables1R9 Basic UDI-DIDate4 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Effets indésirables, Adverse Events
Primary DI / UDI-DI
03701624400036, D-AdverseEventsRB
Basic UDI-DI
37016244EfIndesirables1R9, B-AdverseEventsRB
EMDN Code
Z12040292, Z12040282
Device Class
Class IIb
Class I
Special Device Type
Software
-1192
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000009699

Other devices from Synapse medicine

See all devices from Synapse medicine →

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 (2)

  • EUDAMED 60816810-e8e6-404b-8d90-12c64f7f049a 61 fields · synced 22 Oct 2026
  • EUDAMED D-ADVERSEEVENTSRB|B-ADVERSEEVENTSRB 61 fields · synced 18 May 2026