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SpiroConnect

by MedChip Solutions Limited United Kingdom EUDAMED

Ref SpiroConnect

EMDN Z12150101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060766560007 Basic UDI-DIDate5 Dec 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
SpiroConnect
Model / Reference
SpiroConnect
Primary DI / UDI-DI
05060766560007
Basic UDI-DI
B-05060766560007
EMDN Code
Z12150101 Clinical/diagnostic spirometers
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
GB-MF-000018689
Authorised representative
Advena Limited MT-AR-000000234

Other devices from MedChip Solutions Limited

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 b4af0ee8-d54b-419e-99d0-7ff0c8344834 61 fields · synced 23 Oct 2026