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Aer8

by Aer Beatha AB Sweden EUDAMED

Ref REF-TEST

EMDN R03010380

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735010106AER389PQ Basic UDI-DIDate23 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Aer8 Spacer
Model / Reference
REF-TEST
Primary DI / UDI-DI
07350101060018, 07350101060025
Basic UDI-DI
735010106AER389PQ
Direct Marketing DI
07350101060018
07350101060025
EMDN Code
R03010380 Aerosol therapy systems - accessories
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000041035

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 (2)

  • EUDAMED cdb11cca-173d-4031-a8d6-c2bfc4df671c 61 fields · synced 22 Oct 2026
  • EUDAMED 07350101060025|735010106AER389PQ 61 fields · synced 17 May 2026