Identity
- Trade Name
- EUSRA RF Electrode EUDAMED
- Device Name
- EUSRA RF Electrode EUDAMED
- Model / Reference
- 18-10E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306762290 EUDAMED
- Basic UDI-DI
- 880930676EUSRA_E7F EUDAMEDB-08809306762290 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMEDK0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
EUSRA RF Electrode by Starmed Co., Ltd — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880930676EUSRA_E7F | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880930676EUSRA_E7F | Class IIb | Active |
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Manufacturer
- Manufacturer
- STARmed Co., Ltd.
- EUDAMED SRN
- KR-MF-000008605
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 5c5ed1e9-52e1-4c7c-9545-aa66500f69fc 61 fields · synced May 24, 2026
- EUDAMED daf4beeb-c6c6-4f51-a3bf-1e087a86bccf 61 fields · synced May 18, 2026