Skip to content

SureLead DLSGNK61M

by Authentic Medical

SureLead DLSGNK61M is a Class II device made by Authentic Medical, listed in FDA GUDID since 7 Sep 2022 (UDI-DI B631DLSGNK61M1), 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 NumberB631DLSGNK61M1 UDI-DI Date7 Sep 2022ListedStatusListed 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  • Withdrawn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 set, single-use
Model / reference
DLSGNK61M
Primary DI / UDI-DI
B631DLSGNK61M1
FDA product code
DSA
GMDN term
Electrocardiographic lead set, single-use
Device class
Class II
Regulation number
870.2900
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Electrocardiographic lead set, single-use

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)