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SureLead TCMXAS10C

by Authentic Medical

SureLead TCMXAS10C is a Class II device made by Authentic Medical, listed in FDA GUDID since 25 May 2018 (UDI-DI B631TCMXAS10C1), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 NumberB631TCMXAS10C1 UDI-DI Date25 May 2018ListedStatusListed GUDID: not 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  • Withdrawn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 electrode connector
Model / reference
TCMXAS10C
Primary DI / UDI-DI
B631TCMXAS10C1
FDA product code
DSA
GMDN term
Electrocardiographic electrode connector
Device class
Class II
Regulation number
870.2900
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)).

Other devices from Authentic Medical

See all devices from Authentic Medical →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)