Identity
- Trade Name
- High frequency electrosurgical equipment EUDAMED
- Device Name
- High frequency electrosurgical equipment EUDAMED
- Model / Reference
- SolarE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767873784 EUDAMED
- Basic UDI-DI
- 697176787SolarETH EUDAMED
- EMDN Code
- Z12010999 ELECTROSURGERY INSTRUMENTS - OTHER 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
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
High frequency electrosurgical equipment by Wuxi Beien Surgery Device 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 | 697176787SolarETH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Wuxi Beien Surgery Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000017684
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED cf2b9cca-da5d-42ab-af2b-f5c230a6dff2 61 fields · synced Jul 31, 2026