Identity
- Device Name
- WAXscope kit EUDAMED
- Model / Reference
- 5065005841053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065005841053 EUDAMED
- Basic UDI-DI
- 5065005841WSK64 EUDAMED
- EMDN Code
- Z12149006 DIRECT OUTPATIENT OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The intended purpose of the earwax visualisation device kits is to view the inside of the ear to aid in ear wax removal procedures. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
WAXscope kit by Clearwax Ltd — 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 | 5065005841WSK64 | Class I | Active |
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Manufacturer
- Manufacturer
- Clearwax Ltd
- EUDAMED SRN
- GB-PR-000032246
Sources (1)
- EUDAMED b570b2b8-24a0-49b6-ab86-d33ff393109c 61 fields · synced Jun 19, 2026