Edan Electrocardiograph SE-1201 Pro

by Edan Instruments, Inc. 10 variants

Ref SE-1201 Pro

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222902

+6 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number69444138SE1201PROS8Y Basic UDI-DI 06944413820562UDI-DI	Date13 Mar 2026Registered	StatusActive
United States	GUDID listing GUDID	Number06944413820562 UDI-DI	Date30 Nov 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK222902	Date28 Jul 2023Decided	StatusActive
United States	FDA 510(k) 510(k)	NumberK212278	Date7 Apr 2022Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK171942	Date24 Jan 2018Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK171943	Date25 Sep 2017Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK170995	Date2 Jun 2017Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK120188	Date16 Mar 2012Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK102830	Date2 Dec 2010Issued	StatusActive

Official records

EUDAMED public site Basic UDI-DI 69444138SE1201PROS8Y — open Devices and search for it
AccessGUDID record UDI-DI 06944413820562
FDA 510(k) database 510(k) number K222902
FDA 510(k) database 510(k) number K212278
FDA 510(k) database 510(k) number K171942
FDA 510(k) database 510(k) number K171943
FDA 510(k) database 510(k) number K170995
FDA 510(k) database 510(k) number K120188
FDA 510(k) database 510(k) number K102830

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 69444138SE1201PROS8Y registered 13 Mar 2026 Active
FDA 510(k) K222902 decided 28 Jul 2023 Active· +6 more in the status table
FDA GUDID UDI-DI 06944413820562 listed 30 Nov 2023 Listed

Timeline

9 dated events

2 Dec 2010 Cleared FDA 510(k) K102830
16 Mar 2012 Cleared FDA 510(k) K120188
2 Jun 2017 Cleared FDA 510(k) K170995
25 Sep 2017 Cleared FDA 510(k) K171943
24 Jan 2018 Cleared FDA 510(k) K171942
7 Apr 2022 Cleared FDA 510(k) K212278
28 Jul 2023 Cleared FDA 510(k) K222902
30 Nov 2023 Listed FDA GUDID 06944413820562
13 Mar 2026 Registered EUDAMED 69444138SE1201PROS8Y

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

United States FDA 510(k) Active
European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Full name: Electrocardiograph

Generic name: Electrocardiograph, professional, multichannel
Model / reference: SE-1201 Pro EUDAMED
SE-1201Pro GUDID

Primary DI / UDI-DI: 06944413820562
Basic UDI-DI: 69444138SE1201PROS8Y
510(k) Number: K222902
FDA product code: DPS
EMDN code: Z12050301 General purpose electrocardiographs
GMDN term: Electrocardiograph, professional, multichannel

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

MRI safety: MR Unsafe

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED SE-1201 Pro	GUDID SE-1201Pro
Device class	EUDAMED Class IIa	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN: CN-MF-000009957
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

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Properties

Measuring function
Prescription use
Serial number
Manufacturing date

Other properties (21, all answered No)