Skip to content

Electrocardiograph SL18A

by Edan Instruments, Inc.

Ref SL18A

Electrocardiograph SL18A is an electrocardiograph (EU MDR Class IIa; FDA Class II; FDA product code DPS, Electrocardiograph) made by Edan Instruments, Inc., registered in EUDAMED on 13 Mar 2026 (Basic UDI-DI 69444138SE15SPT), cleared under FDA 510(k) K170995 on 2 Jun 2017 and listed in FDA GUDID since 9 Jun 2017 (UDI-DI 06944413808980), active as of 23 Oct 2026.

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) K170995

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69444138SE15SPT Basic UDI-DI 06944413808980UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413808980 UDI-DI Date9 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK170995 Date2 Jun 2017IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69444138SE15SPT registered 13 Mar 2026 Active
  • FDA 510(k) K170995 decided 2 Jun 2017 Active
  • FDA GUDID UDI-DI 06944413808980 listed 9 Jun 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170995
  2. Listed FDA GUDID 06944413808980
  3. Registered EUDAMED 69444138SE15SPT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Electrocardiograph
Generic name
Electrocardiograph, professional, multichannel
Model / reference
SL18A
Primary DI / UDI-DI
06944413808980
Basic UDI-DI
69444138SE15SPT
510(k) Number
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)