Identity
- Trade Name
- Otinova EUDAMED
- Device Name
- Otinova EUDAMED
- Model / Reference
- 92512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-92512HX EUDAMED
- Basic UDI-DI
- B-92512HX EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Otinova by Circius Pharma AB — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-92512HX | Class I | Active |
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Manufacturer
- Manufacturer
- Circius Pharma AB
- EUDAMED SRN
- SE-MF-000013023
Sources (1)
- EUDAMED 58cfd681-2ab2-41d0-8156-6becda511c4f 61 fields · synced Jun 18, 2026