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
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2024-06-30 |
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2025-04-23 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2024-06-30 |
| Vehicle, Motorized 3-Wheeled | INI | Class 2 | Physical Medicine | No | 2024-09-26 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2026-04-10 |
| Holder, Crutch And Cane, Wheelchair | IMZ | Class 1 | Physical Medicine | No | 2024-06-30 |
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)