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ECG Plug-In SW1003

by Boston Scientific Cardiac Diagnostic Technologies, Inc.

Ref SW1003

ECG Plug-In SW1003 is a device classified as Class IIa in the EU and Class II in the US made by Boston Scientific Cardiac Diagnostic Technologies, Inc., registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI B-00852132007309) and listed in FDA GUDID since 16 Jun 2021 (UDI-DI 00852132007309), active as of 25 Oct 2026.

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

CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00852132007309 Basic UDI-DI 00852132007309UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00852132007309 UDI-DI Date16 Jun 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00852132007309 registered 6 Jul 2026 Active
  • FDA GUDID UDI-DI 00852132007309 listed 16 Jun 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00852132007309
  2. Registered EUDAMED B-00852132007309

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ECG Plug-In
Generic name
Cardiopulmonary physiological parameter analysis software, professional-only
Model / reference
SW1003
Primary DI / UDI-DI
00852132007309
Basic UDI-DI
B-00852132007309
FDA product code
DSI
EMDN code
Z12030292 Vital signs monitoring instruments - medical device software
GMDN term
Cardiopulmonary physiological parameter analysis software, professional-only
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1025
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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: Cardiopulmonary physiological parameter analysis software

Similar devices in this category

Other devices filed under VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Boston Scientific Cardiac Diagnostic Technologies, Inc.

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Properties

  • Prescription use
Other properties (22, all answered No)