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Breezing Med

by TF Health Corp United States EUDAMED

Ref 604internModel B2018

EMDN Z1203020404

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8600055902092010255A Basic UDI-DIDate11 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
B2018, 604intern
Primary DI / UDI-DI
00860005590223
Basic UDI-DI
8600055902092010255A
EMDN Code
Z1203020404 Metabolism equipment
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000043628
Authorised representative
Casus Europe B.V. NL-AR-000037688

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 85b3d787-c5ad-405f-b165-c7185a47a143 61 fields · synced 22 Oct 2026