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Device Explorer · FDA GUDID · GMDN 61866

Inhaler dose sensor

A small, non-sterile, battery-powered device intended to be attached to a portable inhaler [e.g., metered dose inhaler (MDI), dry powder inhaler (DPI), soft mist inhaler (SMI)] to detect when a dose of inhaled medication has been taken, and to transmit this da

US‑registered devices62in commercial distribution
Companies4labelers on GUDID
Single‑use68%of device records
Sterile0%labelled sterile
Prescription19%Rx‑only share
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Share of device records

Reciprocal Labs Corporation4065%
Adherium (Nz) Limited2032%
Voluntis12%
Cognita Labs, Llc12%

Top labelers

CompanyDevicesShare
Reciprocal Labs Corporation4065%
Adherium (Nz) Limited2032%
Voluntis12%
Cognita Labs, Llc12%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HeroTracker SenseHailie Sensor - for use only with Ellipta DPIPropellerCapMedic®Hailie Sensor - for use only with ProAir HFAHailie Sensor - for use only with Symbicort MDIHailie Sensor - for use only with HandiHalerHailie Sensor - for use only with DiskusHailie Sensor - for use only with Bevespi AerospHailie Sensor - for use only with QVAR HFAHailie Sensor - for use only with Flovent HFAHailie Sensor - for use only with Advair HFAHailie Sensor - for use only with Ventolin HFA

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

FDA product codes

CodeNameDevices
CAFNebulizer (Direct Patient Interface)29
BZKSpirometer, Monitoring (W/Wo Alarm)1

GMDN & GCC registration

  • GMDN code 61866 · non‑implantable
  • Single‑use 68% · sterile 0% · Rx‑only 19% · OTC 98%
  • 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.

How many inhaler dose sensor products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Inhaler dose sensor", from 4 companies. The largest labeler is Reciprocal Labs Corporation with 65% of records.

Which FDA product codes apply?

CAF (Nebulizer (Direct Patient Interface)), BZK (Spirometer, Monitoring (W/Wo Alarm))

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?

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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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