FDA Registration Active 🇨🇳 China

INTRADIN (SHANGHAI) MACHINERY CO., LTD

Reg #: 3012781455 · FEI: 3012781455 · Expires 2026
Products
6
Proprietary Names
11
Establishment Types
3
Classifications
6

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Registration Details

Registration Name
INTRADIN (SHANGHAI) MACHINERY CO., LTD
Registration Number
3012781455
FEI Number
3012781455
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No. 118, Duhui Road, Minhang District,
City
Shang Hai Shanghai
Country
CN

Regulatory Submissions

510(k) Number
K243970

Owner / Operator

Firm Name
INTRADIN (SHANGHAI) MACHINERY CO., LTD
Operator Number
10091096
Address
No. 118, Duhui Road, Minhang District,
City
Shang Hai
State
CN-NOTA
Postal Code
201199
Country
CN
Correspondent
Mark Lee

US Agent

Business Name
Regrek LLC
Contact Name
Leeyeo Kee
Address
19 Holly Cove Ln.
City
Dover
State
DE
ZIP
19901
Country
US
Phone
302 6089028

Products

Device Name Product Code
Lift, Patient, Non-Ac-Powered FSA
Wheelchair, Powered ITI
Components, Wheelchair KNN
Vehicle, Motorized 3-Wheeled INI
Aid, Transfer IKX
Holder, Crutch And Cane, Wheelchair IMZ

Proprietary Names

Portable Floor Lift: GUT195, GUT197, GCAT044, GCAT060 GCAT059, ATD301, GUT189, GCAT061, GCAT041, GCAT042; Superhandy Floor Lift: ATD101, GUT167, ATD102, GUT168, ATD103, GUT170, ATD104, GUT169, GCAT046, ATD105, GUT201, Superhandy Portable Wheelchair: GUT166, PMS302, GCAT043 Superhandy Powered Mobility Scooter: PMS101, GUT112, PMS103, GUT140, PMS102, GUT161, PMS104, GUT164, GUT165, PSM105, Superhandy Portable Wheelchair: PMS302, GUT166, PMS303, PMS304, PMS305, PMS306 PMS106, PMS107, PMS108; Superhandy Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) Superhandy Lift Cushion: ATD301, GUT189, GCAT061 Superhandy Electrically Power Wheelchairs Superhandy Powered Mobility Scooter: GUT161, PMS102, GCAT039, GUT164, GUT165, PMS104, GCAT040

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)