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ArtiSeal Vessel Sealing System - ArtiSeal Instruments
EUDAMEDClass IIb (EU MDR)
Ref AS01MModel AS01S
by LivsMed Inc.
Identity
- Trade Name
- ArtiSeal Vessel Sealing System - ArtiSeal Instruments EUDAMED
- Device Name
- Electrosurgical Units with Electrosurgery Instruments EUDAMED
- Model / Reference
- AS01S EUDAMEDAS01M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800042703042 EUDAMED
- Basic UDI-DI
- 88000427ArtiSealI6R EUDAMED
- EMDN Code
- K0201010201,K0201010202 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
ArtiSeal Vessel Sealing System - ArtiSeal Instruments 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 | 88000427ArtiSealI6R | 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 550e8e83-6444-420a-8a54-ffcb4c32c9bf 61 fields · synced Jun 19, 2026