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Ballard* Single Dose Saline Vials, 15 ml, Pink Vials

by Avanos Medical, Inc. United States EUDAMED

Ref 118Model Respiratory Care EMDN R0580

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10609038938063 Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Respiratory Care, 118
Primary DI / UDI-DI
10609038938063
Basic UDI-DI
B-10609038938063
EMDN Code
R0580 Respiratory system suction and dilatation systems - accessories not included in other classes
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000016181
Authorised representative
Avanos Medical Belgium BV BE-AR-000002191

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See all devices from Avanos Medical, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 10609038938063|B-10609038938063 61 fields · synced 24 Oct 2026