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Device Explorer · FDA GUDID · GMDN 42489

Electrocardiographic electrode, reusable

A 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 electrode that i

US‑registered devices121in commercial distribution
Companies14labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription78%Rx‑only share
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Share of device records

Fiab Spa4739%
Curbell Medical Products, Inc.2621%
Apk Technology Co.,Ltd.1512%
Levmed Ltd54%
Shenzhen Launch Electrical Co., Ltd54%
Fukuda Denshi Co.,Ltd.54%
Shenzhen Med-Link Electronics Tech Co.,Ltd.43%
Chungwoo Co., Ltd.43%

Top labelers

CompanyDevicesShare
Fiab Spa4739%
Curbell Medical Products, Inc.2621%
Apk Technology Co.,Ltd.1512%
Levmed Ltd54%
Shenzhen Launch Electrical Co., Ltd54%
Fukuda Denshi Co.,Ltd.54%
Shenzhen Med-Link Electronics Tech Co.,Ltd.43%
Chungwoo Co., Ltd.43%
Premier Heart, Llc32%
Zoll Medical Corporation22%
Nimbleheart, Inc.22%
Philips Medizin Systeme Böblingen Gmbh11%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Levmed ECG 12 Lead Electrodes beltGE HealthcareLaunchAPKMed-linkFUKUDA DENSHINOUNZENIXSURELOCK, CARDIOLINE, ORANGE, 10 PKSURELOCK, MIDMARK, BLUE, 10 PKSURELOCK, CURBELL, RED, 14 PK10-LD EKG CABLE,SNAP,QUINTONSURE LOCK,A34,10 PK,BLUE,PHILIPS/CURBELLSURE LOCK,A34,10 PK,BLUE LEVER,AMBUSURE LOCK,A34,10 PK,ORANGE LEVER,CURBELL/TELLICSURE LOCK,A34,10 PK,BLUE LEVER,MIDMARK

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

FDA product codes

CodeNameDevices
DRXElectrode, Electrocardiograph81
DSACable, Transducer And Electrode, Patient, (Including Connect49
DPSElectrocardiograph4
GEIElectrosurgical, Cutting & Coagulation & Accessories4
DRXElectrode, electrocardiograph2
MKJAutomated external defibrillators (non-wearable)2

GMDN & GCC registration

  • GMDN code 42489 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 78% · 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

No structured size data on the register.

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

How many electrocardiographic electrode, reusable products are registered in the US?

121 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocardiographic electrode, reusable", from 14 companies. The largest labeler is Fiab Spa with 39% of records.

Which FDA product codes apply?

DRX (Electrode, Electrocardiograph), DSA (Cable, Transducer And Electrode, Patient, (Including Connect), DPS (Electrocardiograph), GEI (Electrosurgical, Cutting & Coagulation & Accessories)

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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