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Surelead TCNK2GE3

by Authentic Medical

Surelead TCNK2GE3 is a Class II device made by Authentic Medical, listed in FDA GUDID since 10 Mar 2023 (UDI-DI B631TCNK2GE31), registry data as of 23 Oct 2026.

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.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB631TCNK2GE31 UDI-DI Date10 Mar 2023ListedStatusListed 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  • Withdrawn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
TCNK2GE3
Primary DI / UDI-DI
B631TCNK2GE31
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)