FDA Registration
Active
🇹🇼 Taiwan
NANONEEDLE
Reg #: 3007703432
·
FEI: 3007703432
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Altek Biotechnology Corporation
- Registration Number
- 3007703432
- FEI Number
- 3007703432
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4F, No. 12, Li-Hsin Road, Science-Based Industrial Park
- City
- Hsinchu Hsinchu (City)
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K201134
Owner / Operator
- Firm Name
- Altek Biotechnology Corporation
- Operator Number
- 10029462
- Address
- 4F, No. 12, Li-Hsin Road,, Science-Based Industrial Park
- City
- Hsinchu
- State
- Hsinchu (City)
- Postal Code
- 300
- Country
- TW
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-05-13 |
Proprietary Names
NANONEEDLE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)