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Radio Frequency Plasma Surgical Systems
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref ARS800Ref ARS600
Identity
- Trade Name
- Radio Frequency Plasma Surgical Systems EUDAMED
- Device Name
- Radio Frequency Plasma Surgical Systems EUDAMED
- Model / Reference
- ARS800 EUDAMEDARS600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927155321504 EUDAMED06927155321481 EUDAMED
- Basic UDI-DI
- B-06927155321504 EUDAMEDB-06927155321481 EUDAMED
- EMDN Code
- Z12010905 RADIOSURGICAL UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Radio Frequency Plasma Surgical Systems by Jiangsu Bonss Medical Technology Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221743 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06927155321504 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bonss Medical Technology Co Ltd
- EUDAMED SRN
- CN-MF-000023743
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 10abaa7d-67e2-4741-a698-b72fb84011cd 61 fields · synced Oct 1, 2026
- EUDAMED c7ec7797-a48f-4706-ae85-2b2d3268982d 61 fields · synced May 18, 2026
- FDA 510(k) K221743 1 fields · synced May 18, 2026