# Edan Electrocardiograph SE-1201 Pro

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/electrocardiograph-se-1201-pro>
- Manufacturer: [Edan Instruments, Inc.](https://devicerts.com/manufacturers/edan-instrumentsinc) (China)
- Name in the registry: Electrocardiograph
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: DPS
- EMDN: Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS
- GMDN: Electrocardiograph, professional, multichannel (16231)

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Edan Electrocardiograph SE-1201 Pro is a medical device designed to record the electrical activity of the heart over a period of time. It functions as a measuring device to assist in cardiovascular assessment and diagnostics.

This device is manufactured by Edan Instruments, Inc. and is authorized under both FDA 510(k) and MDR regulations. It is classified as a Class IIa device and is intended for professional clinical environments.

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 69444138SE1201PROS8Y · UDI-DI 06944413820562 · registered 2026-03-13 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 06944413820562 · listed 2023-11-30 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K222902 · decision 2023-07-28 · decision SESE · status: Active · from GUDID
- **510(k)** · FDA 510(k) · United States · K212278 · issued 2022-04-07 · status: Active
- **510(k)** · FDA 510(k) · United States · K171942 · issued 2018-01-24 · status: Active
- **510(k)** · FDA 510(k) · United States · K171943 · issued 2017-09-25 · status: Active
- **510(k)** · FDA 510(k) · United States · K170995 · issued 2017-06-02 · status: Active
- **510(k)** · FDA 510(k) · United States · K120188 · issued 2012-03-16 · status: Active
- **510(k)** · FDA 510(k) · United States · K102830 · issued 2010-12-02 · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Electrocardiograph, professional, multichannel [FDA GUDID (AccessGUDID)]
- Model / reference: SE-1201 Pro [EUDAMED]; SE-1201Pro [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 06944413820562 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 69444138SE1201PROS8Y [EUDAMED]
- 510(k) Number: K222902 [FDA GUDID (AccessGUDID)]
- FDA product code: DPS [FDA GUDID (AccessGUDID)]
- EMDN code: Z12050301 [EUDAMED]
- GMDN term: Electrocardiograph, professional, multichannel (16231) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 870.2340 [FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Measuring function: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Edan Electrocardiograph SE-1201 Pro, Edan Instruments, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/electrocardiograph-se-1201-pro (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/electrocardiograph-se-1201-pro.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/electrocardiograph-se-1201-pro
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.