Identity
- Trade Name
- star Bipolar RF Electrode EUDAMED
- Device Name
- star Bipolar RF Electrode EUDAMED
- Model / Reference
- 17-15s12B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306767318 EUDAMED
- Basic UDI-DI
- B-08809306767318 EUDAMED880930676starBipolar_EZC EUDAMED
- EMDN Code
- K0201010301 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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
star Bipolar RF Electrode by Starmed Co., Ltd — Class IIb — MDR, MDD — 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/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809306767318 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306767318 | 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 bcd0ee18-95c5-49f1-bf01-b4b1c7c3901a 61 fields · synced Jul 17, 2026
- EUDAMED b2c0f900-7b57-4aa1-ad62-4abd7a296df2 61 fields · synced May 17, 2026