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fabian +nCPAP evolution

by ACUTRONIC Medical Systems AG EUDAMED

Active European Union

Ref 122001Model fabian +nCPAP evolution

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-17640140860050 Basic UDI-DIDate21 Sep 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  • Withdrawn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

Model / Reference
fabian +nCPAP evolution, 122001
Primary DI / UDI-DI
17640140860050
Basic UDI-DI
B-17640140860050
EMDN Code
Z1203010503 Neonatal/paediatric pulmonary ventilators
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CH-MF-000017333
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Acutronic Medical Systems AG

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Properties

Show properties
  • Administering Medicine
  • Measuring Function
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No