FDA device listing
Disposable Electrode series Model:VIM-T001/VIS-T002/VIW-T003/VIM-F004/VIS-F005/VIW-F006/VIM-N007,Disposable Electrode…
FDA device listing 1561436697 · SHUYOU INDUSTRIAL MALAYSIA SDN.BHD.
Key facts
| Proprietary names | Disposable Electrode series Model:VIM-T001/VIS-T002/VIW-T003/VIM-F004/VIS-F005/VIW-F006/VIM-N007,Disposable Electrode series Model:VIS-N008/VIW-N009/VIM-B010/VIS-B011/VIW-B012/VIX-A015,Disposable Gorounding Pad series Model:SY-C1/SY-C2,Disposable Gorounding Pad series Model:SY-M1/SY-M2/SY-M3/SY-M4/SY-MW1/SY-MW2/SY-MW3/SY-MW4/SY-S1/SY-S2/SY-S3/SY-S4,Disposable Gorounding Pad series… |
|---|---|
| Owner/operator | SHUYOU INDUSTRIAL MALAYSIA SDN.BHD. |
| Owner/operator number | 10093605 |
| Premarket submissions | K091672 |
| Product codes | GEI, ODR |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories, ODR - Electrosurgical Patient Return Electrode |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SHUYOU INDUSTRIAL MALAYSIA SDN.BHD. |
| Establishment registrations | 3039357913 |
| FEI numbers | 3039357913 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database