GlucoLeader Enhance 2 Blood Glucose Monitoring System
Hmd Biomedical, Inc.
HMD BIOMEDICAL, INC.
FDA Registration(s)#
| 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 Hsinchu(County) TW 305 |
Registered Device Listings#
| 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 |
Product Codes Associated With Registrations#
PMN#
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 Goodli
HMD BIOMEDICAL, INC.
FIA Blood Glucose Monitoring System (G2)
HMD BIOMEDICAL, INC.
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
HMD BIOMEDICAL, INC.
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
HMD BIOMEDICAL, INC.
TEST, BLOOD GLUCOSE SYSTEM
HMD BIOMEDICAL, INC.
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
HMD BIOMEDICAL, INC.
GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
HMD BIOMEDICAL, INC.
GLUCOLEADER VALUE
HMD BIOMEDICAL, INC.