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OTOMER Oil Spray

by Starpharma Spółka Z Ograniczoną Odpowiedzialnoscią

Ref OTOMERModel Ear spray

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08055510249977 Basic UDI-DI 08055510249977UDI-DIDate8 Jul 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  • Withdrawn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
Ear spray olive oil with additives
Model / Reference
Ear spray, OTOMER
Primary DI / UDI-DI
08055510249977
Basic UDI-DI
B-08055510249977
EMDN Code
Q03040299 Ear irrigation devices - other
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
PL-MF-000003825

Other devices from Starpharma Spółka Z Ograniczoną Odpowiedzialnoscią

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