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Device Explorer · FDA GUDID · GMDN 35035

Electrocardiographic electrode, single-use

A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like ele

US‑registered devices1,540in commercial distribution
Companies75labelers on GUDID
Single‑use98%of device records
Sterile1%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Graphic Controls Acquisition Corp20213%
Leonhard Lang Gmbh1157%
Apk Technology Co.,Ltd.986%
3M Company946%
Tyrolmed Gmbh936%
Medimax Tech Inc.845%
Conmed Corporation795%
Fiab Spa654%

Top labelers

CompanyDevicesShare
Graphic Controls Acquisition Corp20213%
Leonhard Lang Gmbh1157%
Apk Technology Co.,Ltd.986%
3M Company946%
Tyrolmed Gmbh936%
Medimax Tech Inc.845%
Conmed Corporation795%
Fiab Spa654%
Cardinal Health 200, Llc584%
Medline Industries, Inc.564%
Medico Electrodes International Limited513%
Nikomed Usa463%

Company = labeler of record on GUDID. 75 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

APKQingdao BrightezPad MRIBittium OmegaSnapFast-Fix ECG ElectrodeBlueSensor VLCECG ElectrodesBlueSensor VLECG ElectrodesBlueSensor TECG ElectrodesBlueSensor SPECG ElectrodesBlueSensor RECG ElectrodesBlueSensor PECG ElectrodesBlueSensor NECG ElectrodesBlueSensor MECG ElectrodesBlueSensor LECG ElectrodesBlueSensor SUECG ElectrodesBlueSensor QECG Electrodes

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

FDA product codes

CodeNameDevices
DRXElectrode, Electrocardiograph1,077
DRXElectrode, electrocardiograph730
DSACable, Transducer And Electrode, Patient, (Including Connect86
DXQblood pressure cuff17
DSHRECORDER, MAGNETIC TAPE, MEDICAL6
GXYElectrode, Cutaneous5

GMDN & GCC registration

  • GMDN code 35035 · non‑implantable
  • Single‑use 98% · sterile 1% · Rx‑only 91% · OTC 1%
  • 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) · 17Width (Inch) · 4Outer Diameter (Inch) · 3Length (Millimeter) · 3Width (Millimeter) · 3Height (Inch) · 2

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

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

1,540 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocardiographic electrode, single-use", from 75 companies. The largest labeler is Graphic Controls Acquisition Corp with 13% of records.

Which FDA product codes apply?

DRX (Electrode, Electrocardiograph), DRX (Electrode, electrocardiograph), DSA (Cable, Transducer And Electrode, Patient, (Including Connect), DXQ (blood pressure cuff)

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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