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ArtiSeal Vessel Sealing System - ArtiSeal Instruments
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref AS01S-FModel AS01SRef AS01L-FRef AS01M-F
by LivsMed Inc.
Identity
- Trade Name
- ArtiSeal Vessel Sealing System - ArtiSeal Instruments EUDAMED
- Device Name
- Electrosurgical Units with Electrosurgery Instruments EUDAMED
- Model / Reference
- AS01S EUDAMEDAS01S-F EUDAMEDAS01L-F EUDAMEDAS01M-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800042703806 EUDAMED08800042703035 EUDAMED08800042703301 EUDAMED08800042703295 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250126 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K241138 | Class IIb | Active |
| 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 (5)
- EUDAMED e548a6d3-0be9-4bf5-9056-23c2691dd08c 61 fields · synced Oct 6, 2026
- EUDAMED 346363a5-3013-4713-b140-f2bdca088c02 61 fields · synced May 17, 2026
- EUDAMED b2cdfb5d-79e6-4be4-868e-53042688b537 61 fields · synced May 17, 2026
- EUDAMED 42e61420-db2c-4ab9-b16e-a8793a92c7f1 61 fields · synced May 18, 2026
- FDA 510(k) K250126 1 fields · synced May 18, 2026