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Device Explorer · FDA GUDID · GMDN 44611

Percutaneous interstitial fluid glucose monitoring system, electrochemical

An assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously

US‑registered devices259in commercial distribution
Companies5labelers on GUDID
Single‑use36%of device records
Sterile25%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Medtronic Minimed, Inc.12247%
Dexcom, Inc.8232%
Abbott Diabetes Care Inc4819%
Medtronic Xomed, Inc.62%
Signos, Inc.10%

Top labelers

CompanyDevicesShare
Medtronic Minimed, Inc.12247%
Dexcom, Inc.8232%
Abbott Diabetes Care Inc4819%
Medtronic Xomed, Inc.62%
Signos, Inc.10%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Signos Glucose Management SystemSimplera Sync™Simplera™Guardian™ 4 Transmitter KitGuardian™ Link (3)Guardian™ 4 TransmitterGuardian™ Transmitter KitGuardian™ ConnectGuardian ™ Link (3)TesterChargerMiniLink® REAL-TimeMiniLink®Guardian™ Sensor (3)Guardian ™ Sensor (3)iPro™2

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

FDA product codes

CodeNameDevices
MDSSensor, glucose, invasive86
MDSSensor, Glucose, Invasive64
QBJIntegrated Continuous Glucose Monitoring System, Factory Cal58
QLGIntegrated Continuous Glucose Monitoring System, Factory Cal57
QOGInjection Data Capture Device55
OZPAutomated insulin dosing device system, single hormonal cont36

GMDN & GCC registration

  • GMDN code 44611 · non‑implantable
  • Single‑use 36% · sterile 25% · Rx‑only 82% · OTC 9%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

No closely related category with 50+ devices.

How many percutaneous interstitial fluid glucose monitoring system, electrochemical products are registered in the US?

259 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Percutaneous interstitial fluid glucose monitoring system, electrochemical", from 5 companies. The largest labeler is Medtronic Minimed, Inc. with 47% of records.

Which FDA product codes apply?

MDS (Sensor, glucose, invasive), MDS (Sensor, Glucose, Invasive), QBJ (Integrated Continuous Glucose Monitoring System, Factory Cal), QLG (Integrated Continuous Glucose Monitoring System, Factory Cal)

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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