Identity
- Trade Name
- Malleable Tip EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Malleable Tip EUDAMEDMalleable Tip, Needle, 6cm shaft length, sterile, single use FDA UDI
- Model / Reference
- SFT-S EUDAMEDSFT-N/S EUDAMEDFDA UDI
- Description
- Malleable Tip, Needle, 6cm shaft length, sterile, single use FDA UDI
Identifiers
- Catalog Number
- SFT-N/S FDA UDI
- Primary DI / UDI-DI
- 00810026180774 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081002618SFT-SKJ EUDAMED
- 510(k) Number
- K183611 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Malleable Tip by Soniquence, LLC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081002618SFT-SKJ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Soniquence, LLC
- EUDAMED SRN
- US-MF-000029810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e7b33030-6b53-4040-93c6-ddcf17c2fcb5 61 fields · synced Jul 14, 2026
- FDA UDI a2fb11f6-c635-4c12-8733-b404e95db237 35 fields · synced May 30, 2026