Identity
- Trade Name
- star RF Electrode EUDAMEDstar RF electrode-Fixed EUDAMED
- Device Name
- star RF Electrode EUDAMEDstar RF electrode-Fixed EUDAMED
- Model / Reference
- 16-30s15F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306764034 EUDAMED
- Basic UDI-DI
- 880930676star_EVG EUDAMEDB-08809306764034 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
star 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 | 880930676star_EVG | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880930676star_EVG | 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 dfca1397-27b9-41a2-8df5-3cdb39a279c5 61 fields · synced Jun 18, 2026
- EUDAMED 5a106a13-3899-400b-82cc-d49b7cc9fee2 61 fields · synced May 18, 2026