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Surelead ADD82DB99F

by Authentic Medical

Surelead ADD82DB99F is a Class II device made by Authentic Medical, listed in FDA GUDID since 27 Mar 2024 (UDI-DI B631ADD82DB99F1), 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 NumberB631ADD82DB99F1 UDI-DI Date27 Mar 2024ListedStatusListed 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  • Withdrawn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
ADD82DB99F
Primary DI / UDI-DI
B631ADD82DB99F1
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)