FDA Registration
Active
🇹🇼 Taiwan
AmCAD-UO
Reg #: 3015218501
·
FEI: 3015218501
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AMCAD BIOMED CORPORATION
- Registration Number
- 3015218501
- FEI Number
- 3015218501
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5F., No.167, Fu Hsing N. Rd., Taipei 105, Taiwan, R.O.C.
- City
- Taipei
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K180867
Owner / Operator
- Firm Name
- AmCad BioMed Corporation
- Operator Number
- 10059547
- Address
- 5F., No.167, Fu Hsing N. Rd., Taipei 105, Taiwan, R.O.C.
- City
- Taipei
- State
- TW-TPE
- Postal Code
- 105
- Country
- TW
- Correspondent
- Joanne Liing
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2019-01-31 |
Proprietary Names
AmCAD-UO
Establishment Types
Manufacture Medical Device