ArtiSeal Vessel Sealing System - ArtiSeal Generator
EUDAMEDFDA UDIClass IIb (EU MDR)
by LivsMed Inc.
Identity
- Trade Name
- ArtiSeal Vessel Sealing System - ArtiSeal Generator EUDAMEDFDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Electrosurgical Units with Electrosurgery Instruments EUDAMEDThe ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments. FDA UDI
- Model / Reference
- ASG-1000 EUDAMEDFDA UDI
- Description
- The ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800042703066 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000427ArtiSealG6M EUDAMED
- 510(k) Number
- K241138 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE 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
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Foot-switch, electrical
ArtiSeal Vessel Sealing System - ArtiSeal Generator by LivsMed Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000427ArtiSealG6M | 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 2498bb76-d5e9-468a-96da-fd159669a48a 61 fields · synced Jul 16, 2026
- FDA UDI 560da952-1800-49aa-93f0-54695bf577f1 36 fields · synced May 29, 2026