FDA Registration
Active
🇨🇳 China
PMS107, PMS108;
Reg #: 3012781455
·
FEI: 3012781455
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- INTRADIN (SHANGHAI) MACHINERY CO., LTD
- Registration Number
- 3012781455
- FEI Number
- 3012781455
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 118, Duhui Road, Minhang District,
- City
- Shang Hai Shanghai
- Country
- CN
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 |
|---|---|---|---|---|---|
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2024-06-30 |
Proprietary Names
PMS107, PMS108;
Powered Mobility Scooter: PMS101, GUT112, PMS103, GUT140, PMS102, GUT161, PMS104, GUT164, GUT165, PSM105, PMS106,
Portable Wheelchair: PMS302, GUT166, PMS303, PMS304, PMS305, PMS306.
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)