Identity
- Trade Name
- star Injectable RF Electrode EUDAMED
- Device Name
- star Injectable RF Electrode EUDAMED
- Model / Reference
- 15-15s40L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306761606 EUDAMED
- Basic UDI-DI
- B-08809306761606 EUDAMED880930676starIn_EGN 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 Injectable 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-08809306761606 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306761606 | 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 a326f5f3-4e21-4b92-b94f-1f4b16e60a5d 61 fields · synced Jul 13, 2026
- EUDAMED 84e8d7d5-dd20-439f-b6bd-407c14003bca 61 fields · synced May 19, 2026