FDA Registration
Active
🇹🇼 Taiwan
Shin-I Medical Manufacturing Co. Ltd.
Reg #: 1000252066
·
FEI: 1000252066
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- Shin-I Medical Manufacturing Co. Ltd.
- Registration Number
- 1000252066
- FEI Number
- 1000252066
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.3, Hai-Ping Road, Kwei Shen
- City
- Taoyuan
- Country
- TW
Owner / Operator
- Firm Name
- Shin-I Medical Manufacturing Co. Ltd.
- Operator Number
- 10048609
- Address
- No.3, Hai-Ping Road, Kwei Shen
- City
- Taoyuan City
- State
- TW-TAO
- Postal Code
- 33348
- Country
- TW
US Agent
- Business Name
- ROC Chinese-European Industrial Research Society
- Contact Name
- Shu-Chen Cheng
- Address
- 2064 Tamarin Dr
- City
- Columbus
- State
- OH
- ZIP
- 43235
- Country
- US
- [email protected]
- Phone
- 614 5888168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2015-02-10 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2015-02-10 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2015-02-10 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2015-02-10 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2015-02-10 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2016-03-25 |
| Lift, Patient, Ac-Powered | FNG | Class 2 | General Hospital | No | 2021-11-30 |
Proprietary Names
Mechanical Wheelchair
Commode Wheelchair
Walker and Rollator
Cane
Powered Hospital Bed
Air Mattress
Powered Patient Lift
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device