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ArtiSential Electrodes, Bipolar Series
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ABF01L-FVRef ABF01-FVRef ABD04L-FVRef ABF01L-FRef ABD02L-FVRef ABD02L-LVRef ABD04S-FVRef ABD01S-FVRef ABD02L-LRef ABD01L-LRef ABF01S-FVRef ABD02S-FVRef ABD04-LVRef ABF01L-LVRef ABD04-FVRef ABD02S-L
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
- ABF01L-FV EUDAMEDABF01-FV EUDAMEDABD04L-FV EUDAMEDABF01L-F EUDAMEDABD02L-FV EUDAMEDABD02L-LV EUDAMEDABD04S-FV EUDAMEDABD01S-FV EUDAMEDABD02L-L EUDAMEDABD01L-L EUDAMEDABF01S-FV EUDAMEDABD02S-FV EUDAMEDABD04-LV EUDAMEDABF01L-LV EUDAMEDABD04-FV EUDAMEDABD02S-L 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
- 08800042701222 EUDAMED08800042701185 EUDAMED08800042702618 EUDAMED08800042700362 EUDAMED08800042701529 EUDAMED08800042701512 EUDAMED08800042702601 EUDAMED08800042701437 EUDAMED08800042700973 EUDAMED08800042700454 EUDAMED08800042701192 EUDAMED08800042701499 EUDAMED08800042702564 EUDAMED08800042701215 EUDAMED08800042702595 EUDAMED08800042700966 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000427BipolarN2 EUDAMED
- 510(k) Number
- K200875 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010602 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USE EUDAMEDK0201010202 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
Dimensions & Sizes
- Size
- Shaft Length — 25 Centimeter 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 (17)
- EUDAMED 8777586b-afba-4669-84ad-559ac4bb5d7f 61 fields · synced Oct 1, 2026
- EUDAMED a3edb378-e0d3-4d0a-973a-27ce04bbe0c5 61 fields · synced May 16, 2026
- EUDAMED e829373f-2b02-4d7d-9437-8f2887f44695 61 fields · synced May 16, 2026
- EUDAMED 60d1f5a4-cdff-4e0a-b10b-38285b063ac6 61 fields · synced May 16, 2026
- EUDAMED 5d30c1be-dde5-404c-8335-55de9f16d549 61 fields · synced May 16, 2026
- EUDAMED 060be302-9cb4-4809-b263-43cdc50d0315 61 fields · synced May 17, 2026
- EUDAMED df1b843e-ae18-4692-ac11-5f7f48a1f2b0 61 fields · synced May 17, 2026
- EUDAMED a9f808cd-4152-4eba-9312-15ac404a92e3 61 fields · synced May 17, 2026
- EUDAMED 5a2042b2-80f5-4566-afdb-6e4122c75141 61 fields · synced May 17, 2026
- EUDAMED c6fe055c-0a00-4641-8f17-f582f264dc60 61 fields · synced May 17, 2026
- EUDAMED cf5604d2-7b4d-42ba-948d-a5eaf887ecb9 61 fields · synced May 17, 2026
- EUDAMED 7f850e40-e164-4872-bee6-c1b20e21e161 61 fields · synced May 18, 2026
- EUDAMED 309ebccb-616c-4fa2-9a9a-9be9594a4ed1 61 fields · synced May 18, 2026
- EUDAMED 72cbbede-1c87-4284-b913-8b3fd3938c1c 61 fields · synced May 19, 2026
- EUDAMED 59087ed6-2eb5-46e3-9ca7-f795640f1a42 61 fields · synced May 19, 2026
- EUDAMED 04708bec-1025-45c9-9ba7-88c7b6f80986 61 fields · synced May 19, 2026
- FDA UDI f008b5b2-27d6-45d5-ad7b-1b9c1893fa27 37 fields · synced May 30, 2026