Identity
- Device Name
- ELVeS® Kit EUDAMED
- Model / Reference
- 503100158-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049059580497 EUDAMED
- Basic UDI-DI
- 404905961NJ EUDAMED
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The ELVeS® Fibers are fiber optic cables for the treatment of varicose veins by photothermolysis, leading to the sealing of the treated vein with laser during surgical procedures. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Varicose vein lasing procedure kit
ELVeS® Kit by CeramOptec GmbH — Class IIa — 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 | 404905961NJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- CeramOptec GmbH
- EUDAMED SRN
- DE-PR-000052739
Sources (1)
- EUDAMED 64b5b089-485c-4ebc-8630-60c452ee221c 61 fields · synced Jul 8, 2026