Identity
- Trade Name
- Plasma Radio Frequency Generator EUDAMED
- Device Name
- Plasma Radio Frequency Generator EUDAMED
- Model / Reference
- ForeMed 600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958289300578 EUDAMED
- Basic UDI-DI
- 695828931002NR EUDAMED
- EMDN Code
- K020399 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Plasma Radio Frequency Generator by Shanghai Forerunner Medical Technology Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 695828931002NR | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
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 d12834a8-c3fa-4409-896b-0aaac0ebe65a 61 fields · synced Jun 18, 2026