Data / Medical devices / Malaysia / Shuyou Industrial Malaysia SDN.BHD.
Shuyou Industrial Malaysia SDN.BHD.: FDA-registered device maker in GEORGE TOWN Perak, Malaysia, 2 510(k) clearances
Shuyou Industrial Malaysia SDN.BHD. is registered with the FDA (registration 3039357913) in GEORGE TOWN Perak, Malaysia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 4, 2009. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3039357913
- Address
- Plot 155,jalan perindustrian bukit minyak 7 kwsn perindustrian bukit minyak 14100 simpang empat PULAU PINANG, GEORGE TOWN Perak, Malaysia, 10300
- Owner or operator
- SHUYOU INDUSTRIAL MALAYSIA SDN.BHD. (10093605)
- Roles
- Specification developer
- First device listed
- June 11, 2025
- Registered through
- 2026
- Brand names listed
- 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 Model:SY-SW1/SY-SW2/SY-SW3/SY-SW4/SY-B1/SY-B2/SY-B3/SY-B4/SY-BW1/SY-BW2/SY-BW3/SY-BW4, Peng's Multifunctional Operative Dissector (PMOD) Model:SY-IA-0/SY-IA-1/SY-IA-2/SY-IA(J)-0, Peng's Multifunctional Operative Dissector (PMOD) Model:SY-IB-0/SY-IB-1/SY-IB-2/SY-IB-3/SY-IIA-0/SY-IIA-1/SY-IIA-2, Peng's Multifunctional Operative Dissector (PMOD) Model:SY-IIA(N)-0/SY-IIA(N)-1/SY-IIA(N)-2/SY-IIB-0/SY-IIB-1/SY-IIB-2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical Patient Return Electrode | ODR | 2 | Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 4, 2009 | K091672 | DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES | GEI | Substantially Equivalent | Shuyou Electric Medical Science Co., Ltd. | accessdata.fda.gov |
| February 10, 2005 | K040780 | ELECTROSURGICAL PENCILS | GEI | Substantially Equivalent | Hangzhou Shuyou Medical Instrument Company, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Electrosurgical Patient Return Electrode
Updated December 4, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.