Identity
- Trade Name
- RUTILIGHT EUDAMED
- Device Name
- RUTILIGHT EUDAMED
- Model / Reference
- RL-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437016917350 EUDAMED
- Basic UDI-DI
- 8437016917RL-013P EUDAMED
- EMDN Code
- K0299 ELECTROSURGERY DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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: Percutaneous radio-frequency ablation system generator
Rutilight by Swan Medical, S.l — 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 | 8437016917RL-013P | Class IIa | Active |
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Manufacturer
- Manufacturer
- Swan Medical, S.l
- EUDAMED SRN
- ES-MF-000001526
Sources (1)
- EUDAMED 300fcef7-f884-4953-baa6-2650ee2fbd11 61 fields · synced Jul 11, 2026