Skip to content

Otosan Cone for the Ear Care 6 Cones

by Otosan Srl

Ref FT001

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8016887CONES22 Basic UDI-DI Date28 Mar 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Otosan Cone for the Ear Care 6 Cones
Otosan Cone for the Ear Care
Device Name
Otosan Cono per L'igiene Dell'orecchio
Model / Reference
FT001
Primary DI / UDI-DI
08016887001148, 08016887001254, 08016887001292, 08016887001063, 08016887001001, 08016887001315, 08016887001209, 08016887001070
Basic UDI-DI
8016887CONES22
EMDN Code
Q0399 ENT devices - other
Device Class
Class I
EU market of registration
France
Belgium
Germany
Greece
Spain
Romania
Finland

Manufacturer details

EUDAMED SRN
IT-MF-000017617

Other devices from Otosan Srl

See all devices from Otosan Srl →

Properties

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