Identity
- Trade Name
- Soni-Cerv LEEP EUDAMEDSoni-Cerv FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Malleable Tip EUDAMEDLEEP Ball electrode FDA UDI
- Model / Reference
- SFT-S EUDAMEDSST-SB3 EUDAMEDFDA UDI
- Description
- LEEP Ball electrode FDA UDI
Identifiers
- Catalog Number
- SST-SB3 FDA UDI
- Primary DI / UDI-DI
- 00810026183690 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
Soni-Cerv LEEP 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 23d26748-c8ad-4d13-b7eb-d6252dafe9dc 61 fields · synced Jun 20, 2026
- FDA UDI 2ff4af68-7fd1-4898-acd6-01c4dc0fb30b 35 fields · synced May 30, 2026