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Monopolar Electrode
EUDAMEDClass IIb (EU MDR)
Ref SW3DModel SFT-SRef SW2DRef SW1D
Identity
- Trade Name
- Monopolar Electrode EUDAMED
- Device Name
- Malleable Tip EUDAMED
- Model / Reference
- SFT-S EUDAMEDSW3D EUDAMEDSW2D EUDAMEDSW1D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810026183751 EUDAMED00810026183744 EUDAMED00810026183737 EUDAMED
- Basic UDI-DI
- 0081002618SFT-SKJ 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
Monopolar Electrode by Soniquence, LLC — Class IIb — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081002618SFT-SKJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Soniquence, LLC
- EUDAMED SRN
- US-MF-000029810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED fbcf71b2-4a4f-41a1-aa6b-b24a931a7005 61 fields · synced Jul 11, 2026
- EUDAMED 08256300-65b4-487e-9f51-ade8979f3e92 61 fields · synced May 16, 2026
- EUDAMED d04dbf37-8681-4459-a63e-5be1979841b9 61 fields · synced May 17, 2026