Identity
- Trade Name
- CLEARscope EUDAMED
- Device Name
- Clearwax Earwax Visualisation Devices EUDAMED
- Model / Reference
- 5065005841008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065005841008 EUDAMED
- Basic UDI-DI
- 5065005841CSAS EUDAMED
- EMDN Code
- Z12149006 DIRECT OUTPATIENT OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CLEARscope 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 | 5065005841CSAS | Class I | Active |
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Manufacturer
- Manufacturer
- Clearwax Ltd
- EUDAMED SRN
- GB-MF-000010886
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 32b129fc-faaa-4978-b301-5ce57c1a43bd 61 fields · synced Jun 17, 2026