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Surelead TCGE2GE5S

by Authentic Medical

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Overview

The Surelead Electrocardiographic lead switching adaptor is a reusable device used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations, enabling devices from different manufacturers to mate together. It typically features implantable functionality, making it an ideal solution for applications where different devices need to be connected.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB631TCGE2GE5S1 UDI-DI Date30 Oct 2024ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Surelead
Generic name
Electrocardiographic lead switching adaptor
Model / reference
TCGE2GE5S
Primary DI / UDI-DI
B631TCGE2GE5S1
FDA product code
IKD
GMDN term
Electrocardiographic lead switching adaptor
Device class
Class II
Regulation number
890.1175
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Electrocardiographic lead switching adaptor

Similar devices in this category

Other devices filed under Electrocardiographic lead switching adaptor.

Other devices from Authentic Medical

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Properties

  • Premarket exempt
  • Lot / batch number
Other properties (13, all answered No)