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ClearEar Extra (Sodium Bicarbonate Ear Drops)

by Zuche Pharmaceuticals Pvt Ltd India EUDAMED

Ref SBD EMDN Q03040299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890616753SBDRQ Basic UDI-DIDate20 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  • Withdrawn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
Sodium Bicarbonate Ear Drops
Model / Reference
SBD
Primary DI / UDI-DI
08906167530041
Basic UDI-DI
890616753SBDRQ
Direct Marketing DI
08906167530041
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 26da11cd-0e85-41c1-a331-37b81e400613 61 fields · synced 22 Oct 2026