FDA Registration
Active
🇹🇼 Taiwan
ZOOM Aspiration Tubing
Reg #: 3014590707
·
FEI: 3014590707
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TAIWAN BIOMATERIAL Company, Ltd.
- Registration Number
- 3014590707
- FEI Number
- 3014590707
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1F, No. 188, Sec. 1, Shengyi Rd., Zhubei City, Hsinchu County
- City
- Zhubei Hsinchu
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K183043
Owner / Operator
- Firm Name
- Taiwan Biomaterial Co., Ltd.
- Operator Number
- 10058651
- Address
- 1F, No. 188, Sec. 1, Shengyi Rd.
- City
- Zhubei
- State
- Hsinchu
- Postal Code
- 302058
- Country
- TW
- Correspondent
- Wen-Hsi Wang
US Agent
- Business Name
- Imperative Care, Inc.
- Contact Name
- Brian Prom
- Address
- 1359 Dell Ave
- City
- Campbell
- State
- CA
- ZIP
- 95008
- Country
- US
- [email protected]
- Phone
- 408 5027548
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2019-05-23 |
Proprietary Names
ZOOM Aspiration Tubing
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)