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CORE 500 Digital Stethoscope - Chestpiece

by Eko Health, Inc. EUDAMEDGUDID

Active European Union and United States

Ref COR500_CHP, COR500_Black, COR500_RED, COR500_GRNModel COR500, CORE 500

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850010298412 UDI-DIDate12 Mar 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

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 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
CORE 500 Digital Stethoscope - Chestpiece EUDAMED
CORE 500 Digital Stethoscope - Champagne Chestpiece GUDID
CORE 500 Digital Stethoscope - Black Chestpiece GUDID
CORE 500 Digital Stethoscope - Wintergreen Chestpiece GUDID
CORE 500 Digital Stethoscope - Ruby Chestpiece GUDID
Generic Name
Electronic acoustic stethoscope
Model / Ref / Catalog
COR500, COR500_CHP, COR500_Black, COR500_RED, COR500_GRN, CORE 500, E8
Primary DI / UDI-DI
00850010298412, 00850010298283, 00850010298740, 00850010298610
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_CHP
COR500_Black
COR500_RED
COR500_GRN
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.

See all devices from Eko Health, Inc. →

Properties

  • 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