A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the q
| Company | Devices | Share |
|---|---|---|
| Trividia Health, Inc. | 88 | 12% |
| Shenzhen Yuwen E-Commerce Co., Ltd. | 39 | 5% |
| Tyson Bioresearch Inc. | 37 | 5% |
| Philosys Co., Ltd | 37 | 5% |
| Bionime Corporation | 36 | 5% |
| Arkray Usa, Inc. | 32 | 4% |
| Ascensia Diabetes Care Us Inc. | 30 | 4% |
| Acon Laboratories, Inc. | 28 | 4% |
| Omnis Health, Llc | 24 | 3% |
| Wal-Mart Stores, Inc. | 24 | 3% |
| I-Sens, Inc. | 19 | 3% |
| Agamatrix, Inc. | 19 | 3% |
Company = labeler of record on GUDID. 81 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 713 |
| CGA | Glucose Oxidase, Glucose | 218 |
| LFR | Glucose Dehydrogenase, Glucose | 166 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 101 |
| CGA | GLUCOSE OXIDASE, GLUCOSE | 41 |
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 38 |
Use these as the dimensions to specify in a tender line.
726 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glucose monitoring system IVD, home-use", from 81 companies. The largest labeler is Trividia Health, Inc. with 12% of records.
NBW (System, Test, Blood Glucose, Over The Counter), CGA (Glucose Oxidase, Glucose), LFR (Glucose Dehydrogenase, Glucose), JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
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.