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ArtiSential Electrodes, Monopolar Series
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref AMHR01-L
by LivsMed Inc.
Identity
- Trade Name
- ArtiSential Electrodes, Monopolar Series EUDAMEDArtisential Monopolar Hook FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Laparoscopic Instruments - Electrodes EUDAMEDSterile Single-use Surgical Instrument used with electrosurgical generator intended to be used during laparoscopic procedure for manipulation of tissue to cauterize and dissect tissue. FDA UDI
- Model / Reference
- AMHR01-L EUDAMEDFDA UDI
- Description
- Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used during laparoscopic procedure for manipulation of tissue to cauterize and dissect tissue. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800042700669 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000427MonopolarS8 EUDAMED
- 510(k) Number
- K230498 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic 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
- 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 — 38 Centimeter FDA UDI
ArtiSential Electrodes, Monopolar 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 | 88000427MonopolarS8 | 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 37af6f9f-bd8d-4cb8-be96-7ad5f0364268 61 fields · synced Jul 12, 2026
- FDA UDI 6c3aac83-2a57-42bd-bf5a-faa71b74d8ba 37 fields · synced May 27, 2026