GlucoLeader Enhance 2 Blood Glucose Monitoring System
Hmd Biomedical, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003902721 | 3003902721 | HMD BIOMEDICAL, INC. | 1 | N | 2026-01-01 | No 181 Minsheng St, Xinpu Township Hsinchu County TW 305 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00389154000204 | GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil) - GL GoodLife Blood Glucose Test Strip(Foil) | 1-855-692-3511 | Sales@gl-diabetes.com |
| 00868665000076 | Rosie SmartMeter Test Strips 50ct(vial) - Rosie SmartMeter Blood Glucose GDH-FAD Test Strips | 1-800-841-1109 | info@nurserosie.com |
| 04711200724820 | GL GoodLife 001 blood glucose monitoring system - GL GoodLife 001 blood glucose monitoring system(Meter/Kit) | 1-877-288-2722 | sales@gl-diabetes.com |
| 04711200724837 | GL GoodLife 001 Blood Glucose Test Strip - GL GoodLife 001 Blood Glucose Test Strip(S50) | 1-877-288-2722 | sales@gl-diabetes.com |
| 04711200724844 | GL GoodLife 001 Glucose Control Solution - GL GoodLife 001 Glucose Control Solution(L1+L2 / BOX) | 1-877-288-2722 | sales@gl-diabetes.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 21223 | 1699194753 | K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | NBW | 2022-08-29 |
| 21223 | 1011808588 | K182428 | GlucoLeader Enhance Blood Glucose Monitoring System | NBW | 2019-05-08 |
| 21223 | 1322893158 | K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 | NBW | 2015-05-14 |
| 21223 | 1602023104 | K131173 | FIA Blood Glucose Monitoring System (G2) | NBW | 2014-09-18 |
| 21223 | 1319426463 | K121433 | GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS | LFR | 2013-02-14 |
| 21223 | 1830247880 | K120064 | TEST, BLOOD GLUCOSE SYSTEM | NBW | 2012-09-05 |
| 21223 | 1990829225 | K113314 | PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | LFR | 2012-11-09 |
| 21223 | 1432861769 | K113307 | GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM | LFR | 2012-07-27 |
| 21223 | 1208554949 | K032985 | GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM | NBW | 2003-10-21 |
| 21223 | 1305095061 | K023279 | GLUCOLEADER VALUE | NBW | 2003-08-04 |
| 21223 | 1017492736 | ||||
| 21223 | 1017530691 | ||||
| 21223 | 1152311887 | ||||
| 21223 | 1173627058 | ||||
| 21223 | 1213746134 | ||||
| 21223 | 1287184395 | ||||
| 21223 | 1867224523 | ||||
| 21223 | 1876714872 | ||||
| 21223 | 2005256308 |
Hmd Biomedical, Inc.
HMD BioMedical Inc.
HMD BIOMEDICAL, INC.
HMD BIOMEDICAL, INC.
HMD BIOMEDICAL, INC.
HMD BIOMEDICAL, INC.
HMD BIOMEDICAL, INC.
HMD BIOMEDICAL, INC.
HMD BIOMEDICAL LLC
HMD BIOMEDICAL, INC.
HMD BIOMEDICAL, INC.
2026-05-08
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