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IN-Nose Blue spray (SP2T-001)

by Enable Innovations SRL Italy EUDAMED

Ref 050182Model Spray nasale SP2T EMDN Q030199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80540851213NQ Basic UDI-DIDate15 Apr 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030120-00 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    3 Feb 2025
    Expires
    2 Feb 2030

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Spray nasale SP2T
Model / Reference
Spray nasale SP2T, 050182
Primary DI / UDI-DI
08054085120162
Basic UDI-DI
80540851213NQ
EMDN Code
Q030199 Nasopharyngeal devices - other
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
IT-MF-000026066

Other devices from Enable Innovations SRL

See all devices from Enable Innovations SRL →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 c6c63a44-828a-4bbf-9d44-5910da307cab 61 fields · synced 24 Oct 2026