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Surelead TCPH2GE123M

by Authentic Medical

Surelead TCPH2GE123M is a Class II device made by Authentic Medical, listed in FDA GUDID since 28 Jan 2025 (UDI-DI B631TCPH2GE123M1), 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 NumberB631TCPH2GE123M1 UDI-DI Date28 Jan 2025ListedStatusListed 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  • Withdrawn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
TCPH2GE123M
Primary DI / UDI-DI
B631TCPH2GE123M1
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

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Properties

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