Skip to content

Mouthpiece Straight Disposable

by Respironics Respiratory Drug Delivery (UK) Ltd

Ref 1098341Model System 22 Mouthpieces

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00606959064638 Basic UDI-DI 00606959064638UDI-DIDate22 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Model / Reference
System 22 Mouthpieces, 1098341
Primary DI / UDI-DI
00606959064638
Basic UDI-DI
B-00606959064638
EMDN Code
R0680 Nebulisation and humidification systems - accessories not included in other classes
Device Class
Class IIa
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
GB-MF-000002292
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Other devices from Respironics Respiratory Drug Delivery (UK) Ltd

See all devices from Respironics Respiratory Drug Delivery (UK) Ltd →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No