Identity
- Device Name
- Orthopedic Kit EUDAMED
- Model / Reference
- 503200835-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049089302762 EUDAMED
- Basic UDI-DI
- 404908963PB EUDAMED
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Procedure pack intended for minimally invasive laser treatment of back and joint pain, including thermal ablation, coagulation and vaporization for tissue shrinkage and denervation. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Varicose vein lasing procedure kit
Orthopedic Kit by Ceram Optec SIA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Varicose vein lasing procedure kit.
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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 | 404908963PB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ceram Optec SIA
- EUDAMED SRN
- LV-PR-000053390
Sources (1)
- EUDAMED 40c87546-208e-4cf0-82b7-c7fa70b5f948 61 fields · synced Jul 8, 2026