Identity
- Trade Name
- VIRTUE RF EUDAMEDFDA UDI
- Generic Name
- Radio-frequency skin surface treatment system FDA UDI
- Device Name
- VIRTUE RF EUDAMEDViruteRF (3 Handpiece) FDA UDI
- Model / Reference
- VIRTUE RF EUDAMEDSH-017 EUDAMEDVirtueRF FDA UDI
- Description
- ViruteRF (3 Handpiece) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800017100821 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000171SH017CK EUDAMED
- 510(k) Number
- K211562 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Radio-frequency skin surface treatment system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Poland 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
Virtue Rf by shenb Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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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 | K211562 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K202415 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 88000171SH017CK | Class IIb | Active |
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Manufacturer
- Manufacturer
- SHENB Co., Ltd.
- EUDAMED SRN
- KR-MF-000021619
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 853b6a90-afae-4520-a69c-2e4fd1bf1157 61 fields · synced Jul 25, 2026
- FDA UDI 35b7ac0f-17fa-4301-b8e0-982075178608 34 fields · synced May 30, 2026
- FDA 510(k) K211562 1 fields · synced May 18, 2026