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BodyGuardian SB2002

by Boston Scientific Cardiac Diagnostic Technologies, Inc.

Ref SB2002

BodyGuardian SB2002 is a device classified as Class I in the EU and Class II in the US made by Boston Scientific Cardiac Diagnostic Technologies, Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 0852132007SB2500GV) and listed in FDA GUDID since 14 Oct 2019 (UDI-DI 00852132007163), active as of 7 Nov 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0852132007SB2500GV Basic UDI-DI 00852132007163UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00852132007163 UDI-DI Date14 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0852132007SB2500GV registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00852132007163 listed 14 Oct 2019 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00852132007163
  2. Registered EUDAMED 0852132007SB2500GV

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  • Withdrawn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
BodyGuardian Mini Bridge EUDAMED
BodyGuardian GUDID
Generic name
Electrocardiographic electrode, single-use
Model / reference
SB2002
Primary DI / UDI-DI
00852132007163
Basic UDI-DI
0852132007SB2500GV
FDA product code
MLN
EMDN code
C020501 ECG electrodes
GMDN term
Electrocardiographic electrode, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2360
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 · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Electrocardiographic electrode, single-use

Similar devices in this category

Other devices filed under ECG ELECTRODES.

Other devices from Boston Scientific Cardiac Diagnostic Technologies, Inc.

See all devices from Boston Scientific Cardiac Diagnostic Technologies, Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)