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Device Explorer · FDA GUDID · GMDN 61821

Electrocardiographic lead set, single-use

A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulate

US‑registered devices1,208in commercial distribution
Companies22labelers on GUDID
Single‑use94%of device records
Sterile0%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Unimed Medical Supplies, Inc.27923%
Med-Dyne, Inc.25121%
Airlife Finland Oy17414%
Lifesync Corporation1099%
Apk Technology Co.,Ltd.887%
Medline Industries, Inc.655%
Cardinal Health 200, Llc514%
Rising Eagle Medical Llc494%

Top labelers

CompanyDevicesShare
Unimed Medical Supplies, Inc.27923%
Med-Dyne, Inc.25121%
Airlife Finland Oy17414%
Lifesync Corporation1099%
Apk Technology Co.,Ltd.887%
Medline Industries, Inc.655%
Cardinal Health 200, Llc514%
Rising Eagle Medical Llc494%
Authentic Medical454%
Owens & Minor Distribution, Inc.393%
Rpi141%
Philips Medical Systems Hsg111%

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

Brand names on the register (sample)

N/AChangke ConnectAPKNihon KohdenPhilipsUnimedsingle pat use ECG 6-lead IEC2single pat use ECG 6-lead IEC1single pat use ECG 4-lead IEC2single pat use ECG 4-lead IEC1Single_Pat_Use_ECG_5_Lead_IEC2Single_Pat_Use_ECG_5_Lead_IEC1Single_Pat_Use_ECG_3_Lead_IEC2Single Pat Use ECG 3-Lead IEC1Med-DyneElectrodes Pharyngeal sEMG

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

FDA product codes

CodeNameDevices
DSACable, Transducer And Electrode, Patient, (Including Connect755
IKDCable, Electrode263
DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECT161
IKDCABLE, ELECTRODE56
DRGTransmitters And Receivers, Physiological Signal, Radiofrequ15
DRXElectrode, electrocardiograph7

GMDN & GCC registration

  • GMDN code 61821 · non‑implantable
  • Single‑use 94% · sterile 0% · Rx‑only 67% · OTC 3%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 243Length (Feet) · 54Circumference (Inch) · 1

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

How many electrocardiographic lead set, single-use products are registered in the US?

1,208 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocardiographic lead set, single-use", from 22 companies. The largest labeler is Unimed Medical Supplies, Inc. with 23% of records.

Which FDA product codes apply?

DSA (Cable, Transducer And Electrode, Patient, (Including Connect), IKD (Cable, Electrode), DSA (CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECT), IKD (CABLE, ELECTRODE)

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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