FDA Registration Active 🇨🇳 China

SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

Reg #: 3006239787 · FEI: 3006239787 · Expires 2026
Products
2
Proprietary Names
13
Establishment Types
3
Classifications
2

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Registration Details

Registration Name
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
Registration Number
3006239787
FEI Number
3006239787
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No. 1269, Huaqing Road, Qingpu District
City
SHANGHAI
Country
CN

Regulatory Submissions

510(k) Number
K081322

Owner / Operator

Firm Name
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO., LTD.
Operator Number
9093889
Address
No. 1269, Huaqing Road, Qingpu District
City
SHANGHAI
State
CN-SH
Postal Code
201707
Country
CN
Correspondent
Jie Huang

US Agent

Business Name
IRC USA
Contact Name
CHARLES MACK
Address
2950 E Lindrick Dr
City
Chandler
State
AZ
ZIP
85249
Country
US
Phone
931 6254938

Products

Device Name Product Code
Coil, Magnetic Resonance, Specialty MOS
System, Nuclear Magnetic Resonance Imaging LNH

Proprietary Names

dS Pediatric Head-Spine Coil 1.5T 8ch (4598-000-2068X) SENSE SPINE COIL 1.5T ODU 4522-133-1724X SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-000-5189X QUAD HEAD COIL T/R 1.5T 4598-002-0529X SENSE CARDIAC COIL 1.5T ODU 4522-133-1726X QUAD HEAD COIL 1.5T 4522-133-1727X SENSE FLEX M COIL 1.5T ODU 4522-133-1717X dS Pediatric Torso-Cardiac Coil 3T 8ch (4598-000-2065X) Knee/Foot/Ankle Coil (4522-150-4097X) SENSE FLEX M COIL 3T ODU 4522-133-1721X QUAD HEAD COIL T/R 3T 4598-001-5223X dS Pediatric Head-Spine Coil 3T 8ch (4598-000-2066X) dS Pediatric Torso-Cardiac Coil 1.5T 8ch (4598-000-2067X)

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)