J25bm, J25bs, J18bs, J49bs
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- J25BM, J25BS, J18BS, J49BS EUDAMEDXE25 FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- XE25, XA25, XW18, XB49 EUDAMED
- Model / Reference
- J25BM, J25BS, J18BS, J49BS EUDAMEDJ25BM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809502330149 EUDAMEDFDA UDI
- Basic UDI-DI
- 880905233VIOLSBPEJTVH EUDAMED
- Direct Marketing DI
- 08809502330149 EUDAMED
- 510(k) Number
- K213612 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010985 ELECTROSURGERY INSTRUMENTS - CONSUMABLES 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
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
J25bm, J25bs, J18bs, J49bs by VIOL Co., Ltd. — 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 | 880905233VIOLSBPEJTVH | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 c51a2678-4e09-4cd3-a76b-47833f0809a1 61 fields · synced Jul 22, 2026
- FDA UDI cc9caa25-2375-4bd2-a9ee-1d117b73f41a 33 fields · synced May 29, 2026
- EUDAMED c51a2678-4e09-4cd3-a76b-47833f0809a1-1 61 fields · synced Jun 10, 2026