FDA.reportPublic FDA data

Glucose analyser IVD, home-use

Definition
An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.
GUDID devices
107
Last updated
2026-06-11 06:05:31

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860003222300Center Health Nano Smart Dongle Blood Glucose Monitoring SystemCENTER HEALTH INCORPORATEDTD-41402020-03-17
00860003222324Center Health Smart Lightning dongle Blood Glucose Monitoring SystemCENTER HEALTH INCORPORATEDTD-41402020-03-17
00353885000482OneTouch UltraminiLifeScan Europe GmbH021-2082017-09-13
00353885000512OneTouch UltraminiLifeScan Europe GmbH021-2112017-09-13
00353885001281OneTouch UltraminiLifeScan Europe GmbH021-4192017-09-13
00353885001311OneTouch UltraminiLifeScan Europe GmbH021-4222017-09-13
00353885002677OneTouch UltraminiLifeScan Europe GmbH021-9112017-09-13
00353885002684OneTouch UltraminiLifeScan Europe GmbH021-9132017-09-13
00353885008136OneTouch UltraminiLifeScan Europe GmbH021-9242017-09-13
00353885008167OneTouch UltraminiLifeScan Europe GmbH021-5142017-09-13
00353885008372OneTouch Ultra2LifeScan U.S. LLC021-1052017-09-13
00353885008716OneTouch VerioLifeScan Europe GmbH022-6572017-09-13
00353885008730OneTouch VerioLifeScan Europe GmbH022-6592017-09-13
00353885010207OneTouch PingANIMAS CORPORATION023-0492017-09-13
00353885010511OneTouch Ultra2LifeScan Europe GmbH023-0652017-09-13
00353885010719OneTouch Verio FlexLifeScan Europe GmbH023-1942017-09-13
00353885010979OneTouch Verio FlexLifeScan Europe GmbH023-2702017-09-13
00353885011464OneTouch UltraminiLifeScan Europe GmbH021-2122017-09-13
00353885011679OneTouch PingLifeScan Europe GmbH023-0492017-12-14
00353885011761OneTouch Verio FlexLifeScan Europe GmbH023-9322018-06-27
00810079240425Teladoc Health, Inc.Teladoc Health, Inc.BG300 - MY2025-10-10
00810079240517Teladoc Health, Inc.Teladoc Health, Inc.BG300 RD2025-10-10
00840423500059VivaGuard Ino Smart Blood Glucose MeterABOUND Diagnostics, Inc.VGM04-6652025-06-06
00850009854001metene BLOOD GLUCOSE MONITORING SYSTEM 100METENE LIMITEDTD-41162026-05-07
00850044118779iHealthiHealth Labs Inc.BG5S2025-12-19
00850044118809iHealthiHealth Labs Inc.AG-6072025-12-19
00850048540781metene BLOOD GLUCOSE MONITORING SYSTEM 150METENE LIMITEDTD-41162026-05-07
00850063675895metene S BLOOD GLUCOSE MONITORING SYSTEM 50METENE LIMITEDS2026-05-07
00883489002594RIGHTEST Blood Glucose Monitoring System Max TelBIONIME CORPORATIONGM7772025-10-17
00898939002338FORAFORA CARE INC.G202017-04-05
06934440101093WellueBioland Technology Ltd.G-427B2021-01-20
06939184600932biolandBioland Technology Ltd.A12023-02-15
06939184630076biolandBioland Technology Ltd.G-427B2021-01-19
00810079240531Teladoc Health, Inc.Teladoc Health, Inc.BG5002026-02-17
00810079240548Teladoc Health, Inc.Teladoc Health, Inc.BG500 RD2026-02-17
00850063675956metene S BLOOD GLUCOSE MONITORING SYSTEMMETENE LIMITEDS2025-12-24
10850044118776iHealthIHEALTH LAB INC.BG5S2025-12-19
10850044118806iHealthIHEALTH LAB INC.AG-6072025-12-19
10856362005156iHealthIHEALTH LAB INC.BG5SKIT2025-12-19
00840423500707VivaGuard Ino Smart Blood Glucose MeterABOUND Diagnostics, Inc.VGM04-6652025-06-06
00840423500004VivaGuard Ino Blood Glucose Meter ABOUND Diagnostics, Inc.VGM01-3732025-06-03
00850063675680metene S BLOOD GLUCOSE MONITORING SYSTEMMETENE LIMITEDS2025-03-31
00850048540798metene BLOOD GLUCOSE MONITORING SYSTEMMETENE LIMITEDTD-41162024-12-12
00860012134007Blood Glucose Monitoring System LIVE TULA TULA HEALTH, INC.TD-42662024-06-15
10850044118233iHealthIHEALTH LAB INC.BG5SKIT2024-05-28
10850044118240iHealthIHEALTH LAB INC.BG5SKIT2024-05-27
00365702702417ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.081092570022023-09-21
00816042011979FORAFORA CARE INC.TN'G Voice2023-06-30
00816042014444FORAFORA CARE INC.Test N'GO Advance Voice2023-06-30
00898939002291ForaCareFORA CARE INC.G30a2023-06-30
06939184600901biolandBioland Technology Ltd.LEVEL 12023-02-15
06939184600918biolandBioland Technology Ltd.LEVEL 22023-02-15
06939184600925biolandBioland Technology Ltd.LEVEL 32023-02-15
16939184600939biolandBioland Technology Ltd.A12023-02-15
00850042929001MIO / TeleRPMMio Labs Inc.VGM042022-09-20
00850042929018MIO / TeleRPMMio Labs Inc.VGS012022-09-20
00850042929025MIO / TeleRPMMio Labs Inc.VGC012022-09-20
00850042929032MIO / TeleRPMMio Labs Inc.I2022-09-20
00850042929049MIO / TeleRPMMio Labs Inc.HH-XIII-T2022-09-20
00850009854018metene BLOOD GLUCOSE MONITORING SYSTEMMETENE LIMITEDTD-41162022-09-06
06958590302520Gochek2Microtech Medical (Hangzhou) Co., Ltd.1017+2021-11-12
06935784450007BioHermes Limpid Blood Glucose MeterWuxi Biohermes Bio & Medical Technology Co.,Ltd.GM 1.02021-05-25
06939184630090telli healthBioland Technology Ltd.G-427B2021-03-06
16934440100000WellueBioland Technology Ltd.G-427B2021-01-20
16939184630073biolandBioland Technology Ltd.G-427B2021-01-19
00739810205885metene BLOOD GLUCOSE MONITORING SYSTEMMETENE LIMITEDTD-41162020-08-20
00739810207742metene BLOOD GLUCOSE MONITORING SYSTEMMETENE LIMITEDTD-41162019-08-19
00365702609105Accu-Chek GuideRoche Diagnostics Operations, Inc.073987940012019-02-28
00365702702394Accu-Chek AvivaRoche Diagnostics Operations, Inc.083403310012019-02-28
00853553005011Livongo Blood Glucose MeterLIVONGO HEALTH, INCBG300C, Kaifa DongGuan2020-02-24
10885017000307FortisCare Self-Monitoring Blood Glucose SystemEPS BIO TECHNOLOGY CORP.EasyMax T1 Pro2020-01-30
00860421000498POPS! one Blood Glucose Monitoring SystemPOPS! DIABETES CARE, INC.TD-41422020-01-23
04710469871498Center Health Blood Glucose Monitoring SystemCENTER HEALTH INCORPORATEDTD-41402019-10-01
00365702702431Accu-Chek GuideRoche Diagnostics Operations, Inc.083870520012019-02-28
04713106027173Center Health Nano Smart Dongle Blood Glucose MoniCENTER HEALTH INCORPORATEDTD-41402019-01-28
04713106029788POPS! one Blood Glucose Monitoring SystemPOPS! DIABETES CARE, INC.TD-41422019-01-28
00853553005349Livongo Blood Glucose MeterLIVONGO HEALTH, INCBG3002018-09-21
00853553005417Livongo Replacement DeviceLIVONGO HEALTH, INCLivongo2018-09-21
00859811007261NuvoMedNUVOMED, INC.NGS50-24/07262019-01-29
00816042010842Pet GlucoFORA CARE INC.Pet Gluco2018-08-07