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Electrocardiograph SE-300B

by Edan Instruments, Inc.

Ref SE-300B

Electrocardiograph SE-300B is an electrocardiograph (EU MDR Class IIa; FDA Class II; FDA product code DPS, Electrocardiograph) made by Edan Instruments, Inc., registered in EUDAMED on 30 Jan 2026 (Basic UDI-DI 69444138SE310sLF) and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06944413800328), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69444138SE310sLF Basic UDI-DI Date30 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413800328 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69444138SE310sLF registered 30 Jan 2026 Active
  • FDA GUDID UDI-DI 06944413800328 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06944413800328
  2. Registered EUDAMED 69444138SE310sLF

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Electrocardiograph
Generic name
Electrocardiograph, professional, multichannel
Model / reference
SE-300B
Primary DI / UDI-DI
06944413800328, 06944413844520
Basic UDI-DI
69444138SE310sLF, 69444138SE3SUC
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
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.

Related devices

Category: Electrocardiograph, professional, multichannel

Similar devices in this category

Other devices filed under GENERAL PURPOSE ELECTROCARDIOGRAPHS.

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)