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Mouthpiece

by Feellife Health Inc. 2 variants

Ref ICU M1Model M1

Mouthpiece (ICU M1) is a Class IIa device made by Feellife Health Inc., registered in EUDAMED on 20 Apr 2026 (Basic UDI-DI 69343253R900134A4B), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69343253R900134A4B Basic UDI-DI Date20 Apr 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Mouthpiece
Model / reference
M1, ICU M1
Primary DI / UDI-DI
06934325307299, 26934325305497
Basic UDI-DI
69343253R900134A4B
Direct marketing DI
06934325307299
26934325305497
EMDN code
R9001 Respiratory mouthpieces
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

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

Similar devices in this category

Other devices filed under RESPIRATORY MOUTHPIECES.

Other devices from Feellife Health Inc.

See all devices from Feellife Health Inc. →

Properties

  • Administering medicine
Other properties (13, all answered No)