Identity
- Device Name
- iCLEARscope kit EUDAMED
- Model / Reference
- 5065005841022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065005841022 EUDAMED
- Basic UDI-DI
- 5065005841ICS2W 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
iCLEARscope 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 | 5065005841ICS2W | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clearwax Ltd
- EUDAMED SRN
- GB-PR-000032246
Sources (1)
- EUDAMED 8f313a40-d89e-466d-be1c-26f63d6f5a8f 61 fields · synced Jun 18, 2026