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ArtiSential Electrodes, Monopolar Series
EUDAMEDClass IIb (EU MDR)
Ref AMHL01L-FRef AMHU01-FRef AMSU01L-FVRef AMHU01L-LRef AMD01-FVRef AMHD01L-FRef AMD01-LRef AMD01L-LRef AMD01L-LV
by LivsMed Inc.
Identity
- Trade Name
- ArtiSential Electrodes, Monopolar Series EUDAMED
- Device Name
- Laparoscopic Instruments - Electrodes EUDAMED
- Model / Reference
- AMHL01L-F EUDAMEDAMHU01-F EUDAMEDAMSU01L-FV EUDAMEDAMHU01L-L EUDAMEDAMD01-FV EUDAMEDAMHD01L-F EUDAMEDAMD01-L EUDAMEDAMD01L-L EUDAMEDAMD01L-LV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800042700768 EUDAMED08800042700614 EUDAMED08800042701772 EUDAMED08800042700591 EUDAMED08800042701635 EUDAMED08800042700584 EUDAMED08800042701574 EUDAMED08800042701598 EUDAMED08800042701628 EUDAMED
- Basic UDI-DI
- 88000427MonopolarS8 EUDAMED
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMEDK0201010402 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY SCISSORS, SINGLE-USE EUDAMEDK0201010202 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY DISSECTORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
ArtiSential Electrodes, Monopolar Series by LivsMed Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000427MonopolarS8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LivsMed Inc.
- EUDAMED SRN
- KR-MF-000011855
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (9)
- EUDAMED 1da687ac-de82-4cf7-9f64-788cf24f5767 61 fields · synced Jul 31, 2026
- EUDAMED d47741a0-6a0e-4056-abd9-e4a81decbf24 61 fields · synced May 16, 2026
- EUDAMED 223732b2-152a-430c-b429-c25b937db18a 61 fields · synced May 17, 2026
- EUDAMED 706b7dac-048c-486f-bc5f-fddc06b57db0 61 fields · synced May 17, 2026
- EUDAMED b67f3699-3f3b-4118-a56e-4adc83b40b70 61 fields · synced May 17, 2026
- EUDAMED 98a0bebf-2306-440f-96ff-5f68840a6607 61 fields · synced May 18, 2026
- EUDAMED 02b6ef0d-4df6-429b-9155-306b5164a66e 61 fields · synced May 18, 2026
- EUDAMED 8bd74d53-7810-4813-beb9-49fd540533db 61 fields · synced May 18, 2026
- EUDAMED ac59bbbd-dbdc-475e-930f-42a648021c00 61 fields · synced May 19, 2026