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Device Explorer · FDA GUDID · GMDN 13680

Diagnostic spirometer, professional

An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory v

US‑registered devices287in commercial distribution
Companies37labelers on GUDID
Single‑use5%of device records
Sterile0%labelled sterile
Prescription51%Rx‑only share
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Share of device records

Vitalograph (Ireland) Limited8530%
Jaeger Medical Gmbh6021%
Eresearchtechnology Gmbh3311%
Medikro Oy83%
S D I Diagnostics Inc72%
C O S M E D Srl72%
Ganshorn Medizin Electronic Gmbh62%
Caire Diagnostics Inc.62%

Top labelers

CompanyDevicesShare
Vitalograph (Ireland) Limited8530%
Jaeger Medical Gmbh6021%
Eresearchtechnology Gmbh3311%
Medikro Oy83%
S D I Diagnostics Inc72%
C O S M E D Srl72%
Ganshorn Medizin Electronic Gmbh62%
Caire Diagnostics Inc.62%
Midmark Corporation62%
Mckesson Medical-Surgical Inc.62%
Ndd Medizintechnik Ag62%
Nspire Health, Inc.52%

Company = labeler of record on GUDID. 37 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SpiroScout SPSpiroScout SP PlusSpiroScoutSPIROVIT SP-250Air NextSTSMiniBox+Pressure gas blowpipeDisposable MouthpieceMouthpieceSpirometerM915-PCD, PCD Spirometer KitM914, Medikro® PrimoM915, Medikro® ProM913, Medikro® NanoM929, Medikro® SpiroStar USB

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

FDA product codes

CodeNameDevices
BZGSpirometer, Diagnostic233
BZGSPIROMETER, DIAGNOSTIC100
BTYCalculator, Predicted Values, Pulmonary Function55
BZCCalculator, Pulmonary Function Data29
DPSElectrocardiograph8
MXASystem, Test, Breath Nitric Oxide6

GMDN & GCC registration

  • GMDN code 13680 · non‑implantable
  • Single‑use 5% · sterile 0% · Rx‑only 51% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Gram) · 2

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

How many diagnostic spirometer, professional products are registered in the US?

287 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Diagnostic spirometer, professional", from 37 companies. The largest labeler is Vitalograph (Ireland) Limited with 30% of records.

Which FDA product codes apply?

BZG (Spirometer, Diagnostic), BZG (SPIROMETER, DIAGNOSTIC), BTY (Calculator, Predicted Values, Pulmonary Function), BZC (Calculator, Pulmonary Function Data)

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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