FDA Registration
Active
🇹🇼 Taiwan
Surgical Face Mask
Reg #: 3016734135
·
FEI: 3016734135
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD.
- Registration Number
- 3016734135
- FEI Number
- 3016734135
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist.
- City
- Taoyuan City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K212863
Owner / Operator
- Firm Name
- TAIWAN COMFORT CHAMP MANUFACTURING Co., LTD.
- Operator Number
- 10068241
- Address
- No. 55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist.,
- City
- Taoyuan City
- State
- TW-TAO
- Postal Code
- 330058
- Country
- TW
- Correspondent
- Ula Ho
US Agent
- Business Name
- Promedic, LLC.
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr Ne
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-09-14 |
Proprietary Names
Surgical Face Mask
Establishment Types
Manufacture Medical Device