Skip to content

EPS! Cerumen® Gotas Auriculares Spray

by AMP BIOTEC S.r.l. EUDAMED

Active European Union

Ref 1516Model Gotas Auriculares spray

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08056201640011 Basic UDI-DIDate2 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
Gotas Auriculares spray, 1516
Primary DI / UDI-DI
08056201640011
Basic UDI-DI
B-08056201640011
EMDN Code
Q030499 Otology devices - other
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
IT-MF-000028485

Other devices from AMP BIOTEC S.r.l.

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