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ArtiSential Electrodes, Monopolar Series (Hand-controlled)
EUDAMEDClass IIb (EU MDR)
Ref 5AMHR01-FH
by LivsMed Inc.
Identity
- Trade Name
- ArtiSential Electrodes, Monopolar Series (Hand-controlled) EUDAMED
- Device Name
- Laparoscopic Instruments - Electrodes EUDAMED
- Model / Reference
- 5AMHR01-FH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800042703783 EUDAMED
- Basic UDI-DI
- 88000427MonopolarS8 EUDAMED
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, 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 (Hand-controlled) 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 (1)
- EUDAMED 4cdea127-2e27-47d3-a6b2-8ee4bdea891b 61 fields · synced Jun 19, 2026