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star Injectable RF Electrode
EUDAMEDClass IIb (EU MDR)
Ref 16-15s40LRef 19-12V_7S5TRef 21-12V_5S7NRef 19-15V_7S5NRef 19-10V_7S5TRef 21-07V_5S7N Ref 19-07V_7S5NRef 19-07V_7S5T
Identity
- Trade Name
- star Injectable RF Electrode EUDAMED
- Device Name
- star Injectable RF Electrode EUDAMED
- Model / Reference
- 16-15s40L EUDAMED19-12V_7S5T EUDAMED21-12V_5S7N EUDAMED19-15V_7S5N EUDAMED19-10V_7S5T EUDAMED21-07V_5S7N EUDAMED19-07V_7S5N EUDAMED19-07V_7S5T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809306761682 EUDAMED08809306764966 EUDAMED08809306768360 EUDAMED08809306764980 EUDAMED08809306764058 EUDAMED08809306764065 EUDAMED08809306768346 EUDAMED08809306764973 EUDAMED
- Basic UDI-DI
- B-08809306761682 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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
star Injectable RF Electrode by Starmed Co., Ltd — Class IIb — MDD, MDR — 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809306761682 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | B-08809306761682 | 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 (9)
- EUDAMED 35881545-5501-4e24-95e4-d755d1e15438 61 fields · synced Jul 24, 2026
- EUDAMED 1224333d-b479-437f-9b25-89485a56d47b 61 fields · synced May 17, 2026
- EUDAMED edaf3581-6ace-4a3e-870e-9469fef90246 61 fields · synced May 17, 2026
- EUDAMED c14800a8-246b-4785-adc0-3dfc0414cc2f 61 fields · synced May 17, 2026
- EUDAMED 1065b28b-cdf0-401a-8a46-305acd069057 61 fields · synced May 17, 2026
- EUDAMED d36b413c-07a6-43d5-9e1a-d935213241ef 61 fields · synced May 18, 2026
- EUDAMED 306e71bc-6e51-43bb-b3b5-a32ae8b1d689 61 fields · synced May 18, 2026
- EUDAMED 7aef969e-682a-40aa-a5fa-e149ecb97135 61 fields · synced May 18, 2026
- EUDAMED ad7f2651-c80e-4beb-9d55-802de153bb8f 61 fields · synced May 19, 2026