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Device Explorer · FDA GUDID · GMDN 61215

Home pharmaceutical management support software

A software package intended to be used by patients at home, and healthcare professionals in a clinical setting, to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their p

US‑registered devices51in commercial distribution
Companies5labelers on GUDID
Single‑use14%of device records
Sterile0%labelled sterile
Prescription41%Rx‑only share
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Share of device records

Welldoc, Inc.4384%
Voluntis36%
Takeda Pharmaceuticals U.S.A., Inc.24%
Dexcom, Inc.24%
Amalgam Rx, Inc.12%

Top labelers

CompanyDevicesShare
Welldoc, Inc.4384%
Voluntis36%
Takeda Pharmaceuticals U.S.A., Inc.24%
Dexcom, Inc.24%
Amalgam Rx, Inc.12%

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

Brand names on the register (sample)

InsuliaiSage RxmyPKFiT for Patients Mobile ApplicationmyPKFiT for Healthcare ProfessionalsDexcom Therapeutic PortalDexcom Therapeutic ServicesWelldocWelldoc RxTempoSmartTempo InsightsOneTouch Reveal Plus RxOneTouch Reveal PlusBlueStarRxBlueStarHealth OptimizerConifer Connect Diabetes Rx

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

FDA product codes

CodeNameDevices
MRZAccessories, Pump, Infusion76
NDCCalculator, Drug Dose75
LNXMedical Computers And Software4
PHYSparse Sample Pk Profile And Dosing Software2
QRXContinuous Glucose Monitor Informed Insulin Dose Calculator2

GMDN & GCC registration

  • GMDN code 61215 · non‑implantable
  • Single‑use 14% · sterile 0% · Rx‑only 41% · OTC 51%
  • 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 home pharmaceutical management support software products are registered in the US?

51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Home pharmaceutical management support software", from 5 companies. The largest labeler is Welldoc, Inc. with 84% of records.

Which FDA product codes apply?

MRZ (Accessories, Pump, Infusion), NDC (Calculator, Drug Dose), LNX (Medical Computers And Software), PHY (Sparse Sample Pk Profile And Dosing Software)

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.

How do I get quotes?

Add home pharmaceutical management support software to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

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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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