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star Bipolar RF Electrode
EUDAMEDClass IIb (EU MDR)
Ref 17-07s18BRef 17-15s18BRef 17-10s18BRef 17-15s15BRef 17-10s15BRef 18-07s15B
Identity
- Trade Name
- star Bipolar RF Electrode EUDAMED
- Device Name
- star Bipolar RF Electrode EUDAMED
- Model / Reference
- 17-07s18B EUDAMED17-15s18B EUDAMED17-10s18B EUDAMED17-15s15B EUDAMED17-10s15B EUDAMED18-07s15B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306760487 EUDAMED08809306760524 EUDAMED08809306760500 EUDAMED08809306760517 EUDAMED08809306760494 EUDAMED08809306760432 EUDAMED
- Basic UDI-DI
- B-08809306760487 EUDAMEDB-08809306760524 EUDAMEDB-08809306760500 EUDAMEDB-08809306760517 EUDAMEDB-08809306760494 EUDAMEDB-08809306760432 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809306760487 | 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 (6)
- EUDAMED 4aed0d3a-8bfe-4bab-94b6-d5ef2d7d4cc6 61 fields · synced Aug 3, 2026
- EUDAMED 388839bd-479c-45ba-98b3-a3d97a6d755f 61 fields · synced May 16, 2026
- EUDAMED 349e3953-9752-4b3f-8304-0f6de90cbe18 61 fields · synced May 17, 2026
- EUDAMED 87d83c1e-4440-4c6c-86a4-6f048050db67 61 fields · synced May 18, 2026
- EUDAMED 88e84725-6d24-462e-9793-c3b70937748d 61 fields · synced May 18, 2026
- EUDAMED 61c3671c-a64d-440f-92fe-db4a362746dd 61 fields · synced May 18, 2026