FDA Registration
Active
🇹🇼 Taiwan
NIV mask
Reg #: 9615826
·
FEI: 3002973578
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FOREMOUNT ENTERPRISE CO., LTD.
- Registration Number
- 9615826
- FEI Number
- 3002973578
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.17, Alley 15, Lane 5,Shenan Street, Shengang District
- City
- Taichung City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K121747
Owner / Operator
- Firm Name
- FOREMOUNT ENTERPRISE CO., LTD.
- Operator Number
- 9042153
- Address
- No.17, Alley 15, Lane 5,, Shenan Street, Shengang District
- City
- Taichung City
- State
- TW-TXG
- Postal Code
- 429
- Country
- TW
- Correspondent
- William - Jiang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2013-12-25 |
Proprietary Names
NIV mask
Establishment Types
Manufacture Medical Device