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CORE 500 Digital Stethoscope - Chestpiece

by Eko Health, Inc. United States EUDAMEDGUDID

Ref COR500_CBLModel COR500, CORE 500 Product code DPSEMDN C9005

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850010298894 UDI-DIDate7 Nov 2025ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number0085001029COR500F2 Basic UDI-DIDate7 Jun 2023RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
CORE 500 Digital Stethoscope - Chestpiece EUDAMED
CORE 500 Digital Stethoscope - Cool Blue Chestpiece GUDID
Generic Name
Electronic acoustic stethoscope
Model / Ref / Catalog
COR500, COR500_CBL, CORE 500, E8
Primary DI / UDI-DI
00850010298894
Basic UDI-DI
0085001029COR500F2, 0850010298COR500MG
510(k) Number
FDA Product Code
DPS, DQD
EMDN Code
C9005 Phonendoscopes and stethoscopes
GMDN Term
Electronic acoustic stethoscope
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2340, 870.1875
Market of Registration
France
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
COR500
COR500_CBL
CORE 500
GUDID
E8
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000034386
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Eko Health, Inc.

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Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function NoEUDAMEDYesEUDAMED
  • Over-the-Counter
  • Serial 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
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED d3446ddd-1bd6-4e42-9dd5-253a6f2c4f62 61 fields · synced 22 Oct 2026
  • EUDAMED 00850010298894|0850010298COR500MG 61 fields · synced 18 Jun 2026
  • FDA UDI 36d4f39a-6ace-4a4c-aaa5-44a699d86f57 35 fields · synced 23 Oct 2026