A collection of devices intended for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure; it is designed to be used for self-testing by a layperson in the home,
| Company | Devices | Share |
|---|---|---|
| Mio Labs Inc. | 15 | 22% |
| O'Well | 14 | 21% |
| Medline Industries, Inc. | 6 | 9% |
| Greater Goods | 5 | 7% |
| Drive Devilbiss Healthcare | 5 | 7% |
| Mhc Medical Products, Llc | 5 | 7% |
| Value Providers Llc | 4 | 6% |
| Prevounce Health, Inc | 3 | 4% |
| Remote Patient Devices Llc | 3 | 4% |
| American Hospital Supply Llc | 2 | 3% |
| Owell | 2 | 3% |
| Jeg & Sons Inc. | 2 | 3% |
Company = labeler of record on GUDID. 13 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 | 30 |
| FMK | Lancet, Blood | 13 |
| DXN | System, measurement, blood-pressure, non-invasive | 7 |
| CGA | Glucose Oxidase, Glucose | 6 |
| DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 6 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Blood glucose/blood pressure monitoring system, home-use", from 13 companies. The largest labeler is Mio Labs Inc. with 22% of records.
NBW (System, Test, Blood Glucose, Over The Counter), FMK (Lancet, Blood), DXN (System, measurement, blood-pressure, non-invasive), CGA (Glucose Oxidase, Glucose)
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.