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smart pft USB

by medical equipment europe GmbH Germany EUDAMED

Ref 10013Model smart pft USB

EMDN Z12150101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04260767090010 Basic UDI-DIDate23 Feb 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
smart pft USB, 10013
Primary DI / UDI-DI
04260767090010
Basic UDI-DI
B-04260767090010
EMDN Code
Z12150101 Clinical/diagnostic spirometers
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000014316

Other devices from medical equipment europe GmbH

Properties & raw data

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

Sources (1)

  • EUDAMED aafcd5d0-9bec-4f52-a235-93644f40d980 61 fields · synced 22 Oct 2026