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Suitestensa

by EBIT s.r.l. EUDAMED

Active European Union

Ref SUITESTENSA

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805221125EBIT.SE.9Q Basic UDI-DIDate17 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Suitestensa
Model / Reference
SUITESTENSA
Primary DI / UDI-DI
08052211250011
Basic UDI-DI
805221125EBIT.SE.9Q
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000040981

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No