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Otovent

EUDAMED

Class I (EU MDR)

Ref 55505Ref 50511Ref 50501Ref 50508Ref 50103Ref 50109Ref 50110

by Circius Pharma AB

Identity

Trade Name
Otovent EUDAMED
Device Name
Otovent EUDAMED
Model / Reference
55505 EUDAMED
50511 EUDAMED
50501 EUDAMED
50508 EUDAMED
50103 EUDAMED
50109 EUDAMED
50110 EUDAMED

Identifiers

Primary DI / UDI-DI
07350133960904 EUDAMED
07350133960881 EUDAMED
07350133960102 EUDAMED
07350133960607 EUDAMED
07350133960249 EUDAMED
07350133960867 EUDAMED
07350133960942 EUDAMED
Basic UDI-DI
735013396Otovent1TV EUDAMED
EMDN Code
Q03040199 EAR DRAINAGE AND VENTILATION DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED
Sweden EUDAMED
Romania EUDAMED
Italy EUDAMED
Portugal EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

Yes

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Otovent by Circius Pharma AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Circius Pharma AB
EUDAMED SRN
SE-MF-000013023

Sources (7)

  • EUDAMED 81ace9ba-6163-43bf-8295-4a0e249f3ce3 61 fields · synced Jul 31, 2026
  • EUDAMED 7d61aa8b-e4cb-41ed-a3f3-9ed02ec24eb6 61 fields · synced May 17, 2026
  • EUDAMED 918ec6cc-0954-452a-9c65-22833ad706ee 61 fields · synced May 17, 2026
  • EUDAMED 59040e1e-2ccf-469b-ab37-b084a74b7f52 61 fields · synced May 17, 2026
  • EUDAMED 119988b9-6946-4f57-bc14-3855bc408894 61 fields · synced May 18, 2026
  • EUDAMED 1f1cd787-a89d-4f38-adb4-c8997b7901de 61 fields · synced May 18, 2026
  • EUDAMED e58036dc-f028-4f5b-ab77-1a52c3b9f30c 61 fields · synced May 19, 2026