FDA Registration
Active
🇹🇼 Taiwan
GlucoLeader Lancet
Reg #: 3003902721
·
FEI: 3003902721
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HMD BIOMEDICAL, INC.
- Registration Number
- 3003902721
- FEI Number
- 3003902721
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No 181 Minsheng St, Xinpu Township
- City
- Hsinchu County
- Country
- TW
Owner / Operator
- Firm Name
- GL DIABETES CORPORATION
- Operator Number
- 9053177
- Address
- 9676 Oviedo St.,
- City
- San Diego
- State
- CA
- Postal Code
- 92129
- Country
- US
US Agent
- Business Name
- Dynamic Biotech, Inc.
- Contact Name
- David Lee
- Address
- 29122 Rancho Viejo Rd., Suite 212
- City
- San Juan Capistrano
- State
- CA
- ZIP
- 92675
- Country
- US
- [email protected]
- Phone
- 949 2180929
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2014-09-18 |
Proprietary Names
GlucoLeader Lancet
Tianjin Huahong Lancet
GlucoLeader Safety Lancet
GoodLife Lancet
SteriLance Lancing Device
GlucoLeader Lancing Device
GoodLife Lancing Device
Loris Safety Lancet
SHANDONG LIANFA Lancing Devices
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device