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NI01 Aposán

by Ningbo Fuwell Imp. & Exp. Co., Ltd. China EUDAMED

Ref NI01Model needle tube type, syringe type

EMDN Q030199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697740431NasalirrigatorC7 Basic UDI-DIDate3 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Nasal irrigator
Model / Reference
needle tube type, syringe type, NI01
Primary DI / UDI-DI
06977404310124
Basic UDI-DI
697740431NasalirrigatorC7
EMDN Code
Q030199 Nasopharyngeal devices - other
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000041510
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Ningbo Fuwell Imp. & Exp. Co., Ltd.

See all devices from Ningbo Fuwell Imp. & Exp. Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 06977404310124|697740431NASALIRRIGATORC7 61 fields · synced 24 Oct 2026