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HypAir PFS

by Medisoft S.A. Belgium EUDAMED

Ref HY-00-01

EMDN Z12150101,Z12159003,Z12159005,Z12159006,Z12159008

Overview

The HypAir PFS is a Class IIa medical device designed for the treatment of hypothyroidism, featuring an implantable device that monitors and regulates thyroid hormone levels in patients.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05407003166019 Basic UDI-DIDate14 Dec 2021RegisteredStatusActive

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

Device Name
HypAir
Model / Reference
HY-00-01
Primary DI / UDI-DI
05407003166019
Basic UDI-DI
B-05407003166019
EMDN Code
Z12150101,Z12159003,Z12159005,Z12159006,Z12159008
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000789

Other devices from Medisoft S.A.

See all devices from Medisoft S.A. →

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 589de7d1-65ec-4c3c-9a2b-d993450e25bb 61 fields · synced 22 Oct 2026