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Device Explorer · FDA GUDID · GMDN 16754

Electrocardiographic recording paper

A device prepared from a thin sheet of fibrous material, typically with preprinted graphics and designed for recording the output of an electrocardiograph (ECG), or other device, in the form of measured physiologic parameters as an electrocardiogram (ECG). Thi

US‑registered devices1,125in commercial distribution
Companies16labelers on GUDID
Single‑use98%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Ab Medica Group, S.A.79971%
Graphic Controls Acquisition Corp16515%
Cardinal Health, Inc.696%
Henry Schein, Inc.182%
Diagramma Ag161%
Fukuda Denshi Co.,Ltd.141%
Welch Allyn, Inc.131%
Bound Tree Medical, Llc50%

Top labelers

CompanyDevicesShare
Ab Medica Group, S.A.79971%
Graphic Controls Acquisition Corp16515%
Cardinal Health, Inc.696%
Henry Schein, Inc.182%
Diagramma Ag161%
Fukuda Denshi Co.,Ltd.141%
Welch Allyn, Inc.131%
Bound Tree Medical, Llc50%
Philips Medical Systems Hsg50%
Airlife Finland Oy50%
Nihon Kohden America, Inc.40%
Philips Medizin Systeme Böblingen Gmbh40%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GE HealthcareFUKUDA DENSHIECG PRINTER PAPER 50MMECG PRINTER PAPER, 100MM100mm x 22m ECG Printer Paper (2/roll)NAViva DiagnosticCuraplexWelch Allyn, Inc.McKessonVermedFetal Monitoring Recording PaperPaperFetal monitoring recording paperKendallnon branded

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

FDA product codes

CodeNameDevices
DSFRecorder, Paper Chart1,009
DSFRECORDER, PAPER CHART190
LMDSystem, Digital Image Communications, Radiological3
DPSELECTROCARDIOGRAPH3
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR2
DPSElectrocardiograph1

GMDN & GCC registration

  • GMDN code 16754 · non‑implantable
  • Single‑use 98% · sterile 0% · Rx‑only 3% · OTC 8%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Feet) · 71Width (Inch) · 67Width (Millimeter) · 1Length (Meter) · 1

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

How many electrocardiographic recording paper products are registered in the US?

1,125 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocardiographic recording paper", from 16 companies. The largest labeler is Ab Medica Group, S.A. with 71% of records.

Which FDA product codes apply?

DSF (Recorder, Paper Chart), DSF (RECORDER, PAPER CHART), LMD (System, Digital Image Communications, Radiological), DPS (ELECTROCARDIOGRAPH)

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.

How do I get quotes?

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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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