Identity
- Trade Name
- Otovent EUDAMED
- Device Name
- Otovent EUDAMED
- Model / Reference
- 50101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350133960218 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
- Sweden 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 735013396Otovent1TV | Class I | Active |
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Manufacturer
- Manufacturer
- Circius Pharma AB
- EUDAMED SRN
- SE-MF-000013023
Sources (1)
- EUDAMED 6fc33e0e-43cb-4938-8c1e-ded7a0401c73 61 fields · synced Jun 20, 2026