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ArtiSeal Vessel Sealing System - ArtiSeal Instruments
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref AS01LModel AS01S
by LivsMed Inc.
Identity
- Trade Name
- ArtiSeal Vessel Sealing System - ArtiSeal Instruments EUDAMEDFDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Electrosurgical Units with Electrosurgery Instruments EUDAMEDArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (sealing) and division (Cutting) of vessels and tissue bundles is desired. FDA UDI
- Model / Reference
- AS01S EUDAMEDAS01L EUDAMEDFDA UDI
- Description
- ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (sealing) and division (Cutting) of vessels and tissue bundles is desired. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800042703059 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000427ArtiSealI6R EUDAMED
- 510(k) Number
- K241138 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010201,K0201010202 EUDAMED
- GMDN Term
- Electrosurgical system 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
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Shaft Length — 41.5 Centimeter FDA UDI
ArtiSeal Vessel Sealing System - ArtiSeal Instruments 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 | 88000427ArtiSealI6R | 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 cb1e36ba-ef49-4ec7-971c-40582b3f6177 61 fields · synced Jul 20, 2026
- FDA UDI 9c92c192-89ba-4c5a-94ce-665fa3d8862d 37 fields · synced May 30, 2026