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Spirometer

by Suzhou Beneware Medical Equipment Co., Ltd. China EUDAMED

Ref SP-01-ENModel SP-01

EMDN Z12150101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06958066408077 Basic UDI-DIDate21 Apr 2023RegisteredStatusActive

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 23 Oct 2026

Device Name
Spirometer systems
Model / Reference
SP-01, SP-01-EN
Primary DI / UDI-DI
06958066408077
Basic UDI-DI
B-06958066408077
EMDN Code
Z12150101 Clinical/diagnostic spirometers
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000015853
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Suzhou Beneware Medical Equipment Co., Ltd.

See all devices from Suzhou Beneware Medical Equipment Co., Ltd. →

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 0b07b4ae-6209-49fa-991a-4eff4394c1fa 61 fields · synced 23 Oct 2026