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Penelope System Test Kit with Deas Sensor - Neonatal

by SOL GROUP LAB S.r.l. Italy EUDAMED

Ref EM1127KIT EMDN Z1203019080

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805571326iNOSYSTEMKITYP Basic UDI-DIDate29 Oct 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  • Withdrawn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 22 Oct 2026

Device Name
iNO SYSTEM KITS
Model / Reference
EM1127KIT
Primary DI / UDI-DI
08055713260298
Basic UDI-DI
805571326iNOSYSTEMKITYP
EMDN Code
Z1203019080 Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories
Device Class
Class IIa
Medical Purpose
Kits for system testing of iNO delivery systems

Manufacturer details

EUDAMED SRN
IT-PR-000030952

Other devices from SOL GROUP LAB S.r.l.

See all devices from SOL GROUP LAB S.r.l. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED c4704d8a-1dfa-4e72-baf2-970ad6ebfd13 61 fields · synced 22 Oct 2026