Skip to content

Spirometer

by Meditech Equipment Co., Ltd 2 variants

Ref Spirox P

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06975911300010 Basic UDI-DI 06975911300010UDI-DIDate1 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
Spirox P
Primary DI / UDI-DI
06975911300010
Basic UDI-DI
B-06975911300010
EMDN Code
Z12150101 Clinical/diagnostic spirometers
Device Class
Class IIa
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000034773
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Meditech Equipment Co., Ltd

See all devices from Meditech Equipment Co., Ltd →

Properties

  • 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