Skip to content

Beneware

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

Ref SP-TB-01Model TB-01

EMDN Z12150180

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69580664TB1201LF Basic UDI-DIDate23 Aug 2024RegisteredStatusActive

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
Disposable turbine
Model / Reference
TB-01, SP-TB-01
Primary DI / UDI-DI
06958066416010
Basic UDI-DI
69580664TB1201LF
EMDN Code
Z12150180 Spirometry instruments - hardware accessories
Device Class
Class I
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
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 (1)

  • EUDAMED 68e51854-394d-40d2-bf19-12f3a2343c4e 61 fields · synced 22 Oct 2026