Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003902721

FEI Number

3003902721

Entity Name

HMD BIOMEDICAL, INC.

City/State/Country

Hsinchu County, TW

Establishment Address

No 181 Minsheng St, Xinpu Township, Hsinchu County 305, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

GL DIABETES CORPORATION (Owner Number: 9053177)

Owner / Operator Contact Address

9676 Oviedo St.,, San Diego, CA 92129, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121433

PMA Number

N/A

All Registered 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 Professional Blood Glucose 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2022-03-25
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2022-03-17
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2007-12-06
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-12-06
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2021-12-06
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2026-05-22
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2014-09-18
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-05-15
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2022-09-15
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-11-17
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-11-17
LFQ	Acid, Uric, Acid Reduction Of Ferric Ion	Clinical Chemistry	Class 1	862.1775	2022-03-17
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-08-01
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-08-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-08-01
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-09-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-09-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-09-19
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-02-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-02-19

Official Correspondent

No official correspondent registered.

US Agent Details

David Lee Business: Dynamic Biotech, Inc. Email: davidlee@ivddreg.com Phone: (949) 2180929

Related Public Records

Same Entity

GL DIABETES CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009129531	GL DIABETES CORPORATION	San Diego, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003902721. Last updated year: 2026. Please use registration number 3003902721 when referencing this establishment in official correspondence.