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SigmaVision® Advanced

by Dr. Sennewald Medizintechnik GmbH Germany EUDAMED

Ref 010-260-DONGLE EMDN Z12039092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberPP12868SIGMAVISION33 Basic UDI-DIDate16 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
010-260-DONGLE
Primary DI / UDI-DI
1312868SIGMAVISIONDONGLE088
Basic UDI-DI
PP12868SIGMAVISION33
Direct Marketing DI
1312868SIGMAVISIONDONGLE088
EMDN Code
Z12039092 Various instruments to support and monitor vital signs - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000007093

Other devices from Dr. Sennewald Medizintechnik GmbH

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 fa831050-40c2-45d0-aa0f-be25d7910b21 61 fields · synced 25 Oct 2026