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Device Explorer · FDA GUDID · GMDN 62538

Glucose monitoring system IVD, point-of-care

A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical pr

US‑registered devices113in commercial distribution
Companies19labelers on GUDID
Single‑use38%of device records
Sterile1%labelled sterile
Prescription48%Rx‑only share
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Share of device records

Nova Biomedical Corporation3935%
Acon Laboratories, Inc.1513%
Bound Tree Medical, Llc1312%
Fresh Test, Llc1211%
Hemocue Ab76%
Hmd Biomedical Inc.44%
Southern Life Systems, Inc.33%
Prodigy Diabetes Care, Llc33%

Top labelers

CompanyDevicesShare
Nova Biomedical Corporation3935%
Acon Laboratories, Inc.1513%
Bound Tree Medical, Llc1312%
Fresh Test, Llc1211%
Hemocue Ab76%
Hmd Biomedical Inc.44%
Southern Life Systems, Inc.33%
Prodigy Diabetes Care, Llc33%
Lifescan Europe Gmbh33%
Arkray Usa, Inc.33%
Lifescan U.S. Llc22%
Stradis Medical, Llc22%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HemoCue® Glucose 201 DM AnalyzerHemoCue® Glucose 201 AnalyzerSmartest Persona II Multi Blood Glucose MonitoriGlucoLeader Enhance Blood Glucose Test Strip(forGoodLife foil packed test stripPRECICHEK AutoCode AC300BEWELL CONNECT MyTensRosieLPOW Blood Glucose Test StripCURO A1cCuraplexFORAOn Call Pro Glucose Control Solution KitOn Call Pro Blood Glucose Test StripsOn Call Pro Blood Glucose MeterOn Call Vivid Pal Blood Glucose Meter

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

FDA product codes

CodeNameDevices
CGAGLUCOSE OXIDASE, GLUCOSE38
NBWSystem, Test, Blood Glucose, Over The Counter21
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER20
CGLELECTRODE, ION BASED, ENZYMATIC, CREATININE16
KHPACID, LACTIC, ENZYMATIC METHOD16
MRVDrink, Glucose Tolerance15

GMDN & GCC registration

  • GMDN code 62538 · non‑implantable
  • Single‑use 38% · sterile 1% · Rx‑only 48% · OTC 31%
  • 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) · 2

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

How many glucose monitoring system ivd, point-of-care products are registered in the US?

113 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glucose monitoring system IVD, point-of-care", from 19 companies. The largest labeler is Nova Biomedical Corporation with 35% of records.

Which FDA product codes apply?

CGA (GLUCOSE OXIDASE, GLUCOSE), NBW (System, Test, Blood Glucose, Over The Counter), NBW (SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER), CGL (ELECTRODE, ION BASED, ENZYMATIC, CREATININE)

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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