Identity
- Trade Name
- star Bipolar RF Electrode EUDAMED
- Device Name
- star Bipolar RF Electrode EUDAMED
- Model / Reference
- 17-35s16B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306767745 EUDAMED
- Basic UDI-DI
- B-08809306767745 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
star Bipolar 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-08809306767745 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306767745 | 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 0e192660-fa15-4b5b-9057-ca011b5852fd 61 fields · synced Jul 29, 2026
- EUDAMED 8e1b941e-060f-42eb-965f-b376b17bb3ec 61 fields · synced May 17, 2026