FDA Registration
Active
🇹🇼 Taiwan
HMD BIOMEDICAL, INC.
Reg #: 3003902721
·
FEI: 3003902721
·
Expires 2026
Products
12
Proprietary Names
49
Establishment Types
5
Classifications
12
Registration Details
- Registration Name
- HMD BIOMEDICAL, INC.
- Registration Number
- 3003902721
- FEI Number
- 3003902721
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No 181 Minsheng St, Xinpu Township
- City
- Hsinchu County
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K032985
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 |
|---|---|---|---|---|---|
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2022-03-25 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2022-03-17 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2007-12-06 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2007-12-06 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2021-12-06 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2026-05-22 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2014-09-18 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2015-11-17 |
| Acid, Uric, Acid Reduction Of Ferric Ion | LFQ | Class 1 | Clinical Chemistry | No | 2022-03-17 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2014-06-27 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2022-03-16 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2022-04-11 |
Proprietary Names
Cucare copper socks
GL GoodLife Copper Socks
GL GoodLife Diabetic Socks
HMD GoodLife Blood Ketone Monitoring System
GlucoLeader Enhance 3 Blood Ketone Monitoring System
GlucoLeader Enhance Blood Ketone Monitoring System
GlucoLeader Enhance Blood Glucose System
Precichek AutoCode AC300~AC305 Blood Glucose Control Test (Range code AC300 to AC305)
FIABiomed Precisa Control Solution L1 & L2
GlucoLeader Lancet
Tianjin Huahong Lancet
GoodLife Lancing Device
GlucoLeader Safety Lancet
GoodLife Lancet
GlucoLeader Lancing Device
SteriLance Lancing Device
Loris Safety Lancet
SHANDONG LIANFA Lancing Devices
GlucoLeader Enhance Blood Glucose Monitoring System
FIA Biomed Precisa Blood Glucose Monitoring System
GL GoodLife 001 blood glucose monitoring system
Metene Enhance Blood Glucose Monitoring System
SugarScan Enhance Blood Glucose Monitoring System
LPOW Blood Glucose Monitoring System
Easy@Home Blood Glucose Test Strip
Easy@Home blood glucose monitoring system
Easy@Home EBG-100BLE Blood Glucose Monitoring System
GlucoLeader Enhance 2 Blood Glucose Monitoring System
GoodLife AC-301~AC-305 Blood Glucose Monitoring System
Rosie SmartMeter NFC Professional Blood Glucose Monitoring System
GoodLife AC-300~AC-305 Professional Blood Glucose Monitoring System
HMD GoodLife Uric Acid Monitoring System
GoodLife AC-300~AC-305 Blood Glucose Monitoring System
Rosie SmartMeter Blood Glucose Monitoring System
PRECICHEK AUTOCODE AC-300, AC-301, AC-302, AC-303, AC-304, and AC-305 blood glucose monitoring systems
FIA Biomed Blood Glucose Monitoring System GV-01
RGB GlucoBuddy Blood Glucose Monitoring System (AC-300)
GoodLife Blood Glucose Monitoring System GV-01
PRECICHEK Cloudia Blood Glucose Monitoring System
GoodLife CS-200 Blood Glucose Monitoring System
GoodLife CS-200 Professional Blood Glucose Monitoring System
FIA Biomed Salut Blood Glucose Monitoring System
FIA Biomed Salut Professional Blood Glucose Monitoring System
RENPHO blood glucose monitoring system
GlucooLeader Software
HMD GoodLife Cholesterol and Triglycerides Monitoring System
HMD Cupric ion Mask
FIA Blood Glucose Monitoring System(G2)
GL GoodLife Blood Glucose Monitoring System(Cloudia)
Establishment Types
Manufacture Medical Device
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device