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penelope 2.0

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

Ref EM1103IM

EMDN Z1203019002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805571326iNOSYSTEMSN9 Basic UDI-DIDate30 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Inhaled Nitric Oxide Therapy Delivery Systems
Model / Reference
EM1103IM
Primary DI / UDI-DI
08055713260250
Basic UDI-DI
805571326iNOSYSTEMSN9
Direct Marketing DI
08055713260250
EMDN Code
Z1203019002 Nitric oxide dispensers
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000025276

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
  • Administering Medicine
  • Measuring Function
Other properties (11)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 6e6de22f-11ae-42c2-905e-c79f3dc54490 61 fields · synced 23 Oct 2026