Identity
- Device Name
- Proctology Kit EUDAMED
- Model / Reference
- 503100261-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049059581005 EUDAMED
- Basic UDI-DI
- 404905964NQ EUDAMED
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The product group Proctology consists of flexible fiberoptic cables that serve to deliver laser light to treat patients during proctological procedures. The fibers are used with or without an appropriate endoscope (proctoscope) for procedures utilizing photothermolytic effects on tissue to treat diseases according to the indications. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Varicose vein lasing procedure kit
Proctology 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 | 404905964NQ | 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 95637f5b-f6f4-43ae-a90f-c839d35ce831 61 fields · synced Jul 8, 2026