Identity
- Trade Name
- star Injectable RF Electrode EUDAMED
- Device Name
- star Injectable RF Electrode EUDAMED
- Model / Reference
- 16-10s10L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306761644 EUDAMED
- Basic UDI-DI
- 880930676starIn_EGN EUDAMEDB-08809306761644 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 Injectable RF Electrode by Starmed Co., Ltd — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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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 | 880930676starIn_EGN | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880930676starIn_EGN | 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 134cdd8f-29f9-48c0-a816-13c4d2373215 61 fields · synced Jul 25, 2026
- EUDAMED ecaa6200-bfe4-4c5a-982b-fc0ba39f2a13 61 fields · synced May 19, 2026