Identity
- Trade Name
- SYLFIRM X EUDAMEDFDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- SYLFIRM X EUDAMED
- Model / Reference
- SYLFIRM X EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809502330101 EUDAMEDFDA UDI
- Basic UDI-DI
- 880905233VIOLHFSUFXVF EUDAMED
- Direct Marketing DI
- 08809502330101 EUDAMED
- 510(k) Number
- K200185 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
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sylfirm X by VIOL Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K213612 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K200185 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880905233VIOLHFSUFXVF | Class IIb | Active |
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Manufacturer
- Manufacturer
- VIOL Co., Ltd.
- EUDAMED SRN
- KR-MF-000014556
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED 63b3e753-61c0-4c33-b8e6-c84f3ed7aaa2 61 fields · synced Jul 13, 2026
- FDA UDI edf19c12-f29b-48d8-8a4c-392a89cf5103 33 fields · synced May 30, 2026
- FDA 510(k) K213612 1 fields · synced May 18, 2026