Identity
- Trade Name
- star Bipolar RF Electrode EUDAMED
- Device Name
- star Bipolar RF Electrode EUDAMED
- Model / Reference
- 17-25s16B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306767356 EUDAMED
- Basic UDI-DI
- 880930676starBipolar_EZC EUDAMEDB-08809306767356 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria EUDAMEDFrance 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- Symmetry Olsen — Olsen Medical · Class II
- FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
- 33cm Laparoscopic L-Wire Split; Blue PTFE; Black Insulation; PL — XODUS MEDICAL, INC. · Class II
- 4" Blade Tip Ext Ins; Stainless Steel; Blue Ins; Black Ext Ins — XODUS MEDICAL, INC. · Class II
- CONMED — Conmed Corporation · Class II
- HT-DT-NTW45 — Zhejiang Jinhua Huatong Medical Appliance Co., Ltd · Class IIb
- COLORADO — Stryker Leibinger · Class II
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 | 880930676starBipolar_EZC | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880930676starBipolar_EZC | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- STARmed Co., Ltd.
- EUDAMED SRN
- KR-MF-000008605
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4b03a034-bb87-4dad-8c77-3940a236abc2 61 fields · synced Jul 14, 2026
- EUDAMED 84016cc5-23ac-4342-96f3-a547a9cf811a 61 fields · synced May 19, 2026