Identity
- Device Name
- Plasma Radio Frequency Electrodes EUDAMED
- Model / Reference
- FS C04-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958289305610 EUDAMED
- Basic UDI-DI
- B-06958289305610 EUDAMED
- EMDN Code
- K02030101 RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Plasma Radio Frequency Electrodes by Shanghai Forerunner Medical Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06958289305610 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shanghai Forerunner Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027294
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 5e150663-b805-43e2-88e0-8aa3761e7880 61 fields · synced Jun 19, 2026