Identity
- Trade Name
- Otocur 25 ml EUDAMED
- Device Name
- Otocur EUDAMED
- Model / Reference
- 3028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430020483028 EUDAMED
- Basic UDI-DI
- B-06430020483028 EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Otocur 25 ml by Galena Pharma Oy — Class IIa — 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-06430020483028 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (1)
- EUDAMED 638b49de-8cd7-4e48-a943-304faaa7ad6e 61 fields · synced Jul 22, 2026