Identity
- Trade Name
- Bipolar cable EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- Bipolar Cable EUDAMEDBipolar Cable, European, Sterile/Disposable (1 pc) FDA UDI
- Model / Reference
- SIEC-DJX EUDAMEDSBCD-EU/1 EUDAMEDFDA UDI
- Description
- Bipolar Cable, European, Sterile/Disposable (1 pc) FDA UDI
Identifiers
- Catalog Number
- SBCD-EU/1 FDA UDI
- Primary DI / UDI-DI
- 00810026181740 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081002618SIEC-DJX29 EUDAMED
- 510(k) Number
- K190336 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02010203 ELECTROSURGERY CONNECTION CABLES, SINGLE-USE EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, single-use FDA UDI
Classification
- Device Class
- Class I 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: Electrical-only medical device connection cable, reusable
Bipolar cable by Soniquence, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- MICTEC CONNECTION CABLE — SONTEC INSTRUMENTS, INC. · Class II
- ECG Cable — Edan Instruments,Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081002618SIEC-DJX29 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Soniquence, LLC
- EUDAMED SRN
- US-MF-000029810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 724f9dab-614e-487c-b949-1dbcabd07c99 61 fields · synced Jul 9, 2026
- FDA UDI d967fad7-145c-44c3-a2a4-36469be6d3f6 35 fields · synced May 30, 2026