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Otowax (Olive Oil Ear Spray)

by Zuche Pharmaceuticals Pvt Ltd India EUDAMED

Ref OLS EMDN Q03040299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890616753OLSSY Basic UDI-DIDate30 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Olive Oil Ear Spray
Model / Reference
OLS
Primary DI / UDI-DI
08906167530263
Basic UDI-DI
890616753OLSSY
Direct Marketing DI
08906167530263
EMDN Code
Q03040299 Ear irrigation devices - other
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
IN-MF-000010593
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zuche Pharmaceuticals Pvt Ltd

See all devices from Zuche Pharmaceuticals Pvt Ltd →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 82487e8b-6401-4f0b-a8bc-c949d395aad4 61 fields · synced 22 Oct 2026