Identity
- Trade Name
- CLEARlite 2 EUDAMED
- Device Name
- Clearwax Earwax Visualisation Devices EUDAMED
- Model / Reference
- 5065005841152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065005841152 EUDAMED
- Basic UDI-DI
- 5065005841CLAC EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Category: Endoscopic light source unit, line-powered
CLEARlite 2 by Clearwax Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5065005841CLAC | 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 2432c497-1836-4456-9719-c0b262bd88d2 61 fields · synced Jun 18, 2026