FDA Registration
Active
🇹🇼 Taiwan
Lancing device
Reg #: 3004130086
·
FEI: 3004130086
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- EPS BIO TECHNOLOGY CORP.
- Registration Number
- 3004130086
- FEI Number
- 3004130086
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 8, R&D Rd. III, Hsinchu Science Park,
- City
- Hsinchu
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K222472
Owner / Operator
- Firm Name
- EPS BIO TECHNOLOGY CORP.
- Operator Number
- 9058147
- Address
- No. 8, R&D Road III
- City
- Hsinchu Science Park
- State
- TW-HSQ
- Postal Code
- 30076
- Country
- TW
- Correspondent
- Silvia Lai
US Agent
- Business Name
- Oak Tree International Holdings Inc.
- Contact Name
- Steve Kim
- Address
- 9550 S Eastern Ave Ste 253
- City
- Las Vegas
- State
- NV
- ZIP
- 89123
- Country
- US
- [email protected]
- Phone
- 702 4627295
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2024-03-29 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2024-03-29 |
Proprietary Names
Lancing device
Establishment Types
Export Device to the United States But Perform No Other Operation on Device