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Device Explorer · FDA GUDID · GMDN 12391

Wearable multiple physiological parameter recorder, reusable

An electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemo

US‑registered devices81in commercial distribution
Companies22labelers on GUDID
Single‑use37%of device records
Sterile0%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Somnomedics Ag1721%
Biointellisense, Inc.1620%
Sibel Health Inc.1114%
Pranaq Pte. Ltd.67%
Huxley Medical, Inc.56%
Bodimetrics, Llc34%
Biofourmis Singapore Pte. Ltd.34%
Withings22%

Top labelers

CompanyDevicesShare
Somnomedics Ag1721%
Biointellisense, Inc.1620%
Sibel Health Inc.1114%
Pranaq Pte. Ltd.67%
Huxley Medical, Inc.56%
Bodimetrics, Llc34%
Biofourmis Singapore Pte. Ltd.34%
Withings22%
Biosensics Llc22%
Peerbridge Health, Inc.22%
Corsano Health B.V.22%
Ava Sciences-Fmtc Gmbh22%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OxitoneAcuPebbleLEAF™SOMNOwatch® eco redSOMNOwatch™ eco orangeSOMNOwatch® eco greenSOMNOwatch® eco blueSOMNOwatch plus ACTI + PLM (Activity)SOMNOwatch plus ACTI + PLMSOMNOwatch® ecoFoot StrapWatch Strap - Size LPLM Sensor SetPLM Sensor Set (Activity)DOMINO lightAbdomen/Thorax Belt - Size XXL

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

FDA product codes

CodeNameDevices
MNRVentilatory Effort Recorder31
DRGTransmitters And Receivers, Physiological Signal, Radiofrequ29
DQAOximeter13
BZQMonitor, Breathing Frequency12
FLLThermometer, Electronic, Clinical10
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio9

GMDN & GCC registration

  • GMDN code 12391 · non‑implantable
  • Single‑use 37% · sterile 0% · Rx‑only 77% · OTC 12%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Lumen/Inner Diameter (Millimeter) · 3

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

How many wearable multiple physiological parameter recorder, reusable products are registered in the US?

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Wearable multiple physiological parameter recorder, reusable", from 22 companies. The largest labeler is Somnomedics Ag with 21% of records.

Which FDA product codes apply?

MNR (Ventilatory Effort Recorder), DRG (Transmitters And Receivers, Physiological Signal, Radiofrequ), DQA (Oximeter), BZQ (Monitor, Breathing Frequency)

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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