Identity
- Trade Name
- Otex Sodium Bicarbonate EUDAMED
- Device Name
- Otex Sodium Bicarbonate Ear Drops EUDAMED
- Model / Reference
- 100140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016379299308 EUDAMED
- Basic UDI-DI
- B-05016379299308 EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Otex Sodium Bicarbonate by Diomed Developments Limited — 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-05016379299308 | Class I | Active |
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Manufacturer
- Manufacturer
- Diomed Developments Limited
- EUDAMED SRN
- GB-MF-000004862
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 45fd5a66-060f-435a-8e62-094a9493d145 61 fields · synced Jul 10, 2026