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South Korea·KR-MF-000021619
Last updated May 25, 2026
Information
- Country
- South Korea
- Address
- 74, Achasan-ro, Seongdong-gu, Seoul, 04782, Republic of Korea, Seoul, South Korea
- Website
- www.shenb.com/
- —
- —
- [email protected]
- Phone
- +82-2-466-0010
- PRRC Contact
- Mingyu Kim
- EUDAMED SRN
- KR-MF-000021619
- FDA FEI Number
- —
- DUNS Number
- 690425442
Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PlaDuo PRO System | PlaDuo PRO System | FDA UDI | Class II | Active |
| Sterile Micro Needle Cartridge | Exact RF TIP | FDA UDI | Class II | Active |
| VIVACE Microneedle Cartridge | SH-TIP | FDA UDI | Class II | Active |
| Virtue RF | Virtue RF | FDA UDI | Class II | Active |
| Sterile Micro Needle Cartridge | Deep RF 12PIN TIP | FDA UDI | Class II | Active |
| Sterile Micro Needle Cartridge | Exact RF TIP II | FDA UDI | Class II | Active |
| Sterile Micro Needle Cartridge | Deep RF 36PIN TIP | FDA UDI | Class II | Active |
| Sterile Micro Needle Cartridge | Smart RF 36PIN TIP II | FDA UDI | Class II | Active |
| Vybe Rf | VYBE RF | FDA UDI | Class II | Active |
| VIVACE Electrosurgical System | VIVACE | FDA UDI | Class II | Active |
| PlaDuo System | PlaDuo | FDA UDI | Class II | Active |
| VirtueRF | VirtueRF | FDA UDI | Class II | Active |
| Virtue RF Microneedle Cartridge | SmartRF 36PIN TIP | FDA UDI | Class II | Active |
| Sterile Micro Needle Cartridge | Smart RF 36PIN TIP | FDA UDI | Class II | Active |
| Pladuo, Plasmaduo | Plasma Surgical Unit | EUDAMEDFDA UDI | Class IIb | Active |
| Silshape | SH-008 | EUDAMED | Class IIb | Active |
| AF Laser | K221363 | EUDAMEDFDA 510(k) | Class II | Active |
| Sunny Plus (Sunny) | K251649 | FDA 510(k) | Class II | Active |
| VYBE RF Electrosurgical System | K230968 | FDA 510(k) | Class II | Active |
| Vybe RF II | K241535 | FDA 510(k) | Class II | Active |
| VIVACE Electrosurgical Device | K193070 | FDA 510(k) | Class II | Active |
| Sunny | K242241 | FDA 510(k) | Class II | Active |
| PlaDuo System | K201735 | FDA 510(k) | Class II | Active |
| PlaDuo System | K232223 | FDA 510(k) | Class II | Active |
| Vivaline | SH-009 | EUDAMED | Class IIa | Active |
| Diacore | High-frequency electromagnetic stimulator | EUDAMED | Class IIa | Active |
| Virtue Rf | SH-017 | EUDAMEDFDA UDI | Class IIb | Active |
| Vivace, Vivace Ii | SH-004 | EUDAMEDFDA UDI | Class IIb | Active |
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