Identity
- Trade Name
- star RF electrode-Fixed EUDAMEDstar RF Electrode EUDAMED
- Device Name
- star RF electrode-Fixed EUDAMEDstar RF Electrode EUDAMED
- Model / Reference
- 16-35s10F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306764294 EUDAMED
- Basic UDI-DI
- B-08809306764294 EUDAMED880930676star_EVG 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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
star RF electrode-Fixed by Starmed Co., Ltd — Class IIb — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809306764294 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306764294 | 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 50805f47-cd67-4fff-9d65-fe1f9aa8da22 61 fields · synced Jul 16, 2026
- EUDAMED 9d30de8e-0d31-4c6c-94db-ba4fc78d0460 61 fields · synced May 18, 2026