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Surelead DLSMRT54F

by Authentic Medical

Surelead DLSMRT54F is a Class II device made by Authentic Medical, listed in FDA GUDID since 10 Sep 2021 (UDI-DI B631DLSMRT54F1), 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 NumberB631DLSMRT54F1 UDI-DI Date10 Sep 2021ListedStatusListed 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  • Withdrawn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
DLSMRT54F
Primary DI / UDI-DI
B631DLSMRT54F1
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 in this category

Other devices filed under Electrocardiographic lead set, single-use.

Other devices from Authentic Medical

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Properties

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