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Welch Allyn Harvey Elite Stethoscope

by Welch Allyn, Inc. EUDAMEDGUDID

Active European Union

Ref 5079-125Model 901039

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732094GMN901039F9 Basic UDI-DIDate18 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00732094000504 UDI-DIDate15 Aug 2023ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Welch Allyn Harvey Elite Stethoscope EUDAMED
Welch Allyn, Inc. GUDID
Generic Name
Mechanical external stethoscope
Model / Ref / Catalog
901039, 5079-125
Primary DI / UDI-DI
00732094000504
Basic UDI-DI
0732094GMN901039F9
FDA Product Code
LDE
EMDN Code
C9005 Phonendoscopes and stethoscopes
GMDN Term
Mechanical external stethoscope
Device Class
Class I
Regulation Number
870.1875
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000013394
Authorised representative
Welch Allyn Limited IE-AR-000000768

Other devices from Welch Allyn, Inc.

See all devices from Welch Allyn, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No