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Icu TP1

by Feellife Health Inc. United States EUDAMED

Ref ICU ME2Model ICU TP1

EMDN R0680

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69343253R068025M57 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive

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
Icu TP1
Model / Reference
ICU TP1, ICU ME2
Primary DI / UDI-DI
06934325306995
Basic UDI-DI
69343253R068025M57
Direct Marketing DI
06934325306995
EMDN Code
R0680 Nebulisation and humidification systems - accessories not included in other classes
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000000782
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Feellife Health Inc.

See all devices from Feellife Health Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f36c91f1-ed91-4304-adff-6dcddc944044 61 fields · synced 22 Oct 2026