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Ear Spray with Propionate

by PROPONENT Biotech AG

Ref PSES01Model PSES

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-++G565PSESJG Basic UDI-DI ++G565PSESJGUDI-DIDate24 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Proponent Solutions - Ear Spray
Model / Reference
PSES, PSES01
Primary DI / UDI-DI
++G565PSESJG
Basic UDI-DI
B-++G565PSESJG
EMDN Code
Q03040299 Ear irrigation devices - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000036207
Authorised representative
Ursatec GmbH DE-AR-000035691

Other devices from PROPONENT Biotech AG

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