Identity
- Trade Name
- RF Ablation Electrode Kits EUDAMED
- Device Name
- Radiofrequency Ablation System EUDAMED
- Model / Reference
- SS-RFAS2-1007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972304751326 EUDAMED
- Basic UDI-DI
- 69723047500016P EUDAMED
- EMDN Code
- K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Radio-frequency ablation system
RF Ablation Electrode Kits by Surgnova Healthcare Technologies (zhejiang) Co., Ltd. — Class IIb — 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 | 69723047500016P | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000014087
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 80a54741-214f-4da1-9326-696c51573509 61 fields · synced Sep 18, 2026