Skip to content

Otinova

by Circius Pharma AB 3 variants

Ref 92510

Otinova (92510) is a medical device (EU MDD Class I; EMDN category otology devices) made by Circius Pharma AB, registered in EUDAMED on 2 Feb 2024 (Basic UDI-DI B-92510HT), active as of 25 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-92510HT Basic UDI-DI D-92510HTUDI-DIDate2 Feb 2024RegisteredStatusActive

Official records

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / reference
92510
Primary DI / UDI-DI
D-92510HT
Basic UDI-DI
B-92510HT
EMDN code
Q030499 Otology devices - other
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000013023

Similar devices in this category

Other devices filed under OTOLOGY DEVICES - OTHER.

Other devices from Circius Pharma AB

  • Otovent GO

    Class I

  • Otovent® 51003

    Unclassified

  • Otovent® 50105

    Unclassified

  • Otovent® 55502

    Unclassified

See all devices from Circius Pharma AB →

Properties

Other properties (12, all answered No)