FDA Registration
Active
🇹🇼 Taiwan
BAPA Tube for T-TAS 01
Reg #: 3016579901
·
FEI: 3016579901
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SUNPHORIA CO., LTD.
- Registration Number
- 3016579901
- FEI Number
- 3016579901
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11F-1, No.51, Hengyang Rd.,, Zhongzheng Dist.,
- City
- Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K191364
Owner / Operator
- Firm Name
- Sunphoria Co., Ltd.
- Operator Number
- 10062637
- Address
- 11F-1, No.51, Hengyang Rd.,, Zhongzheng Dist.,
- City
- Taipei City
- State
- TW-TPE
- Postal Code
- 10045
- Country
- TW
- Correspondent
- Ying-Che Chang
US Agent
- Business Name
- Hikari Dx, Inc.
- Contact Name
- Jeffrey Dahlen
- Address
- 11435 Merritage Court
- City
- San Diego
- State
- CA
- ZIP
- 92131
- Country
- US
- [email protected]
- Phone
- 619 7420203
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Automated Platelet Aggregation | JOZ | Class 2 | Hematology | No | 2020-02-24 |
Proprietary Names
BAPA Tube for T-TAS 01
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility