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V-Cure Radiofrequency Electrosurgical Ablation System Generator
EUDAMEDClass IIb (EU MDR)
Ref NONEModel GENESIS-V01
Identity
- Trade Name
- V-Cure Radiofrequency Electrosurgical Ablation System Generator EUDAMED
- Device Name
- Radiofrequency Electrosurgical Ablation System Generator EUDAMED
- Model / Reference
- GENESIS-V01 EUDAMEDNONE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424210134 EUDAMED
- Basic UDI-DI
- B-06975424210134 EUDAMED
- EMDN Code
- K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
V-Cure Radiofrequency Electrosurgical Ablation System Generator by Resonant Medical Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06975424210134 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Resonant Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032264
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 567727f1-6a23-4ddc-b966-07e762e9676a 61 fields · synced Jun 18, 2026