FDA Registration
Active
🇹🇼 Taiwan
GOSTAR CO., LTD.
Reg #: 3030626362
·
FEI: 3030626362
·
Expires 2026
Products
3
Proprietary Names
8
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- GOSTAR CO., LTD.
- Registration Number
- 3030626362
- FEI Number
- 3030626362
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2F., No. 65, Wuquan 7th Rd., Wugu Dist.
- City
- New Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K222810
Owner / Operator
- Firm Name
- GOSTAR CO., LTD.
- Operator Number
- 10090367
- Address
- 2F., No. 65, Wuquan 7th Rd., Wugu Dist.
- City
- New Taipei City
- State
- TW-NWT
- Postal Code
- 248020
- Country
- TW
- Correspondent
- Pei-Fen Yang
US Agent
- Business Name
- ForaCare Inc
- Contact Name
- Sophia Wu
- Address
- 893 Patriot Dr Ste D,
- City
- Moorpark
- State
- CA
- ZIP
- 93021
- Country
- US
- [email protected]
- Phone
- 805 4988188
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2024-03-20 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2024-03-19 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2024-03-19 |
Proprietary Names
TD-7301 Peak Flow Meter
FORA Spiro10b Peak Flow Meter
TD-5010 Lancing Device and TD-5084 Sterile Lancets
TD-5010 Lancing Device ; TD-THIN Sterile Lancets
LIVE TULA Sterile lancets
FORA LANCING DEVICE ; FORA STERILE LANCETS
TD-5011 Lancing Device ; TD-THIN Sterile Lancets
FORA gojji LANCING DEVICE ; FORA gojji STERILE LANCETS
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility