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Audio Tone

by Global Pharma Cm S.a Poland EUDAMED

Ref 88EN-4

EMDN Q03040199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-88EN-4ZK Basic UDI-DIDate27 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Spray do ucha
Model / Reference
88EN-4
Primary DI / UDI-DI
D-88EN-4ZK
Basic UDI-DI
B-88EN-4ZK
EMDN Code
Q03040199 Ear drainage and ventilation devices - other
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000034662

Other devices from Global Pharma Cm S.a

See all devices from Global Pharma Cm S.a →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 1e4efd2d-d3fa-46f6-8012-d5e83e0838b4 61 fields · synced 22 Oct 2026