Identity
- Trade Name
- EUSRA RF electrode EUDAMED
- Device Name
- EUSRA RF electrode EUDAMED
- Model / Reference
- 18-07E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306762283 EUDAMED
- Basic UDI-DI
- B-08809306762283 EUDAMED880930676EUSRA_E7F EUDAMED
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMEDK0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDBulgaria 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 — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809306762283 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306762283 | 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 0d4ec660-b7e5-4d77-869f-95691ff9b101 61 fields · synced Jul 18, 2026
- EUDAMED fd593e0e-7c71-4d0d-8457-2db6abbc89f1 61 fields · synced May 18, 2026