Identity
- Device Name
- Orthopedic Kit EUDAMED
- Model / Reference
- 502200835 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049059519602 EUDAMED
- Basic UDI-DI
- 404905963NN EUDAMED
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The Orthopedic Fiber product group consists of fiber optic cables designed to transmit laser light from an external source to targeted tissue during minimally invasive treatment of back and joint pain. These fibers enable precise energy delivery for thermal ablation, coagulation and vaporization used in orthopedic context for tissue shrinkage and denervation. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Varicose vein lasing procedure kit
Orthopedic Kit by CeramOptec GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Varicose vein lasing procedure kit.
- Bare Fiber — Ceram Optec SIA · Class IIa
- Laser Surgery Fiber 550µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
- Disposable Laser Surgery Fiber 550µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
- Laser Surgery Fiber - Orthopaedic Surgery Fiber for PLDD — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
- Laser Surgery Fiber - Radial Emission Fiber 600µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
- VenaCure EVLT — ANGIODYNAMICS, INC · Class II
- Laser Surgery Fiber - Disposable 600 micron laser fiber — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
- Laser Surgery Fiber - Dental Surgery Fiber 400µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
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 | 404905963NN | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CeramOptec GmbH
- EUDAMED SRN
- DE-PR-000052739
Sources (1)
- EUDAMED a8d33853-7207-44d7-ab85-d6d6cb489983 61 fields · synced Aug 1, 2026