Consulting Wallah › Device Explorer › IVD & laboratory › Glucose analyser IVD, home-use
Device Explorer · FDA GUDID · GMDN 62645

Glucose analyser IVD, home-use

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-car

US‑registered devices57in commercial distribution
Companies18labelers on GUDID
Single‑use23%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Metene Limited1119%
Fora Care Inc.916%
Bioland Technology Ltd.712%
Mio Labs Inc.59%
Teladoc Health, Inc.47%
Livongo Health, Inc35%
Roche Diagnostics Operations, Inc.35%
Center Health Incorporated24%

Top labelers

CompanyDevicesShare
Metene Limited1119%
Fora Care Inc.916%
Bioland Technology Ltd.712%
Mio Labs Inc.59%
Teladoc Health, Inc.47%
Livongo Health, Inc35%
Roche Diagnostics Operations, Inc.35%
Center Health Incorporated24%
Ihealth Labs Inc.24%
Abound Diagnostics, Inc.24%
Foracare Texas, Inc24%
Microtech Medical (Hangzhou) Co., Ltd.12%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Gochek2telli healthbiolandBioHermes Limpid Blood Glucose MeterWellueFORAForaCareRIGHTEST Blood Glucose Monitoring System Max TelPOPS! one Blood Glucose Monitoring SystemBlood Glucose Monitoring System LIVE TULACenter Health Smart Lightning dongle Blood GlucoCenter Health Nano Smart Dongle Blood Glucose MoNuvoMedLivongo Replacement DeviceLivongo Blood Glucose Metermetene Blood Glucose Test Strips (50pcs*2)

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NBWSystem, Test, Blood Glucose, Over The Counter56
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER16
LFRGlucose Dehydrogenase, Glucose5
LFRGlucose dehydrogenase, glucose5
CGAGlucose Oxidase, Glucose4
CGAGLUCOSE OXIDASE, GLUCOSE4

GMDN & GCC registration

  • GMDN code 62645 · non‑implantable
  • Single‑use 23% · sterile 0% · Rx‑only 2% · OTC 44%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Needle Gauge (Gauge) · 10

Use these as the dimensions to specify in a tender line.

How many glucose analyser ivd, home-use products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glucose analyser IVD, home-use", from 18 companies. The largest labeler is Metene Limited with 19% of records.

Which FDA product codes apply?

NBW (System, Test, Blood Glucose, Over The Counter), NBW (SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER), LFR (Glucose Dehydrogenase, Glucose), LFR (Glucose dehydrogenase, glucose)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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