FDA Registration
Active
🇹🇼 Taiwan
Model : NANO, NANO-PL, NANO-EL
Reg #: 3009453853
·
FEI: 3009453853
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD
- Registration Number
- 3009453853
- FEI Number
- 3009453853
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1F., No.59, Luke 2nd Rd.,, Luzhu Dist.
- City
- Kaohsiung
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K103061
Owner / Operator
- Firm Name
- BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD
- Operator Number
- 10037488
- Address
- 1F., No.59, Luke 2nd Rd.,, Luzhu Dist.
- City
- Kaohsiung
- State
- TW-KHH
- Postal Code
- 821
- Country
- TW
- Correspondent
- Yu-Jung Su
US Agent
- Business Name
- Qualtech Consulting LLC
- Contact Name
- Chi-Feng Chang
- Address
- 532 Arboles Street
- City
- Monterey Park
- State
- CA
- ZIP
- 91754
- Country
- US
- [email protected]
- Phone
- 626 3455899
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Acupuncture, Single Use | MQX | Class 2 | General Hospital | No | 2011-07-18 |
Proprietary Names
Model : NANO, NANO-PL, NANO-EL
BIOMATE STERILE ACUPUNCTURE NEEDLE
Establishment Types
Manufacture Medical Device