Skip to content

Brisa

by Temedica GmbH EUDAMED

Active European Union

Ref Brisa

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number06059219GMN00195 Basic UDI-DIDate26 Apr 2022RegisteredStatusActive

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  • Withdrawn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

Device Name
Brisa
Model / Reference
Brisa
Primary DI / UDI-DI
04260592190015
Basic UDI-DI
06059219GMN00195
Direct Marketing DI
04260592190015
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006165

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