Identity
- Trade Name
- Otex Express Combi EUDAMED
- Device Name
- Otex Express Combi EUDAMED
- Model / Reference
- 100097 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016379000072 EUDAMED
- Basic UDI-DI
- 5016379DioEar2JS EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Otex Express Combi pack is used to help remove hardened wax from the ear canal. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Otex Express Combi by Diomed Developments Limited — Class IIa — 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 | 5016379DioEar2JS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Diomed Developments Ltd.
- EUDAMED SRN
- UK-PR-000039959
Sources (1)
- EUDAMED cd76e527-6684-4523-bd5a-81b29d3ab71f 61 fields · synced Jun 18, 2026