FDA Registration Active 🇲🇾 Malaysia

SHUYOU INDUSTRIAL MALAYSIA SDN.BHD.

Reg #: 3039357913 · FEI: 3039357913 · Expires 2026
Products
2
Proprietary Names
11
Establishment Types
1
Classifications
2

Registration Details

Registration Name
SHUYOU INDUSTRIAL MALAYSIA SDN.BHD.
Registration Number
3039357913
FEI Number
3039357913
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Plot 155,jalan perindustrian bukit minyak 7 kwsn perindustrian bukit minyak 14100 simpang empat PULAU PINANG
City
GEORGE TOWN Perak
Country
MY

Regulatory Submissions

510(k) Number
K040780

Owner / Operator

Firm Name
SHUYOU INDUSTRIAL MALAYSIA SDN.BHD.
Operator Number
10093605
Address
Plot 155,jalan perindustrian bukit minyak 7 kwsn perindustrian bukit minyak 14100 simpang empat PULAU PINANG
City
GEORGE TOWN
State
Perak
Postal Code
10300
Country
MY
Correspondent
Jianwei Chen

US Agent

Business Name
GRZAN GROUP INC.
Contact Name
Andy Smith
Address
8825 53 AVE ELMHURST
City
Elmhurst
State
NY
ZIP
11373
Country
US
Phone
332 2015192

Products

Device Name Product Code
Electrosurgical, Cutting & Coagulation & Accessories GEI
Electrosurgical Patient Return Electrode ODR

Proprietary Names

Peng's Multifunctional Operative Dissector (PMOD) Model:SY-IIB(N)-0/SY-IIB(N)-1/SY-IIB(N)-2/SY-IIB(JN)-0 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-IIIB-0/SY-IIIB-1/SY-IIIB-2/SY-IIIB(Q)-0/SY-IIIX(N)-1 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 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-IIIA-0/SY-IIIA-1/SY-IIIA-2/SY-IIIA(N)-0/SY-IIIA(N)-1 Disposable Gorounding Pad series Model:SY-C1/SY-C2 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 Disposable Electrode series Model:VIS-N008/VIW-N009/VIM-B010/VIS-B011/VIW-B012/VIX-A015 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 Electrode series Model:VIM-T001/VIS-T002/VIW-T003/VIM-F004/VIS-F005/VIW-F006/VIM-N007

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility