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Tempo SD5030O

by Hemasource

Tempo SD5030O is a Class I device made by Hemasource, listed in FDA GUDID since 8 Dec 2022 (UDI-DI 00891153001965), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00891153001965 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Tempo
Generic name
Mechanical external stethoscope
Model / reference
SD5030O
Description
Tempo Dual Head Stethoscope Assembled - Orange
Primary DI / UDI-DI
00891153001965
FDA product code
LDE
GMDN term
Mechanical external stethoscope
Device class
Class I
Regulation number
870.1875
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)