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Otomer

by ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche 2 variants

Ref I47V10480Model sale unit, 100 ml

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 linked in EUDAMED

A group certificate may exist

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-I47V10480JX Basic UDI-DI D-I47V10480JXUDI-DIDate20 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Otomer Spray It
Model / Reference
sale unit, 100 ml, I47V10480
Primary DI / UDI-DI
D-I47V10480JX
Basic UDI-DI
B-I47V10480JX
EMDN Code
Q030499 Otology devices - other
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027942

Other devices from ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche

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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