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Plasma Surgical System Generator
EUDAMEDClass IIb (EU MDR)
Ref F12000103Model RF100
Identity
- Device Name
- Plasma Surgical System Generator EUDAMED
- Model / Reference
- RF100 EUDAMEDF12000103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941906286959 EUDAMED
- Basic UDI-DI
- 697221054CE150000017L EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal 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
Category: Foot-switch, electrical
Plasma Surgical System Generator by Star Sports Medicine 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 | 697221054CE150000017L | Class IIb | Active |
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Manufacturer
- Manufacturer
- Star Sports Medicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000027866
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 04e15eb9-cf72-43c4-b24a-70801d545616 61 fields · synced Jun 18, 2026