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ArtiSential Electrodes, Bipolar Series
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ABD02-F
by LivsMed Inc.
Identity
- Trade Name
- ArtiSential Electrodes, Bipolar Series EUDAMEDArtisential Bipolar Precise Dissector FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
- Device Name
- Laparoscopic Instruments - Electrodes EUDAMEDSterile Single-use Surgical Instrument used with electrosurgical generator intended to be used during lapaproscopic procedure for manipulation of tissue to cauterize, grasp and dissect tissue. FDA UDI
- Model / Reference
- ABD02-F EUDAMEDFDA UDI
- Description
- Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used during lapaproscopic procedure for manipulation of tissue to cauterize, grasp and dissect tissue. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800042700942 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000427BipolarN2 EUDAMED
- 510(k) Number
- K200875 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010202 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY DISSECTORS, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ArtiSential Electrodes, Bipolar Series by LivsMed Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000427BipolarN2 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- LivsMed Inc.
- EUDAMED SRN
- KR-MF-000011855
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (2)
- EUDAMED dfc1b5e8-2da7-4757-9968-0797ce04c049 61 fields · synced Jun 18, 2026
- FDA UDI f8a70552-e13b-4a64-9802-e37d39e568a3 36 fields · synced May 27, 2026