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CORE 500 Digital Stethoscope - Earpiece

by Eko Health, Inc. EUDAMEDGUDID

Active European Union and United States

Ref CAC500_BLK, CAC500_FSG, CAC500_FRP, CAC500_FBL, CAC500_FOW, CAC500_PRP, CAC500_ROG, CAC500_GRN, CAC500_FRB, CAC500_FEL, CAC500_FCB, CAC500_FBY, CAC500_CHP, CAC500_FMA, CAC500_FOT, CAC500_RED, CAC500_FGRModel COR500, CORE 500

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850010298450 UDI-DIDate18 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 - Earpiece EUDAMED
CORE 500 Digital Stethoscope FIGS Earpiece - Seaglass GUDID
CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue GUDID
CORE 500 Digital Stethoscope - Wintergreen Earpiece GUDID
CORE 500 Digital Stethoscope - Ruby Earpiece GUDID
CORE 500 Digital Stethoscope - Amethyst Earpiece GUDID
CORE 500 Digital Stethoscope FIGS Earpiece - Mauve GUDID
CORE 500 Digital Stethoscope - Champagne Earpiece GUDID
CORE 500 Digital Stethoscope FIGS Earpiece - Grey GUDID
CORE 500 Digital Stethoscope - Black Earpiece GUDID
CORE 500 Digital Stethoscope FIGS Earpiece - Black GUDID
CORE 500 Digital Stethoscope FIGS Earpiece - Orange Taffy GUDID
CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response Pink GUDID
CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue GUDID
CORE 500 Digital Stethoscope - Rose Gold Earpiece GUDID
CORE 500 Digital Stethoscope FIGS Earpiece - Elderberry GUDID
CORE 500 Digital Stethoscope FIGS Earpiece - Off White GUDID
Generic Name
Electronic acoustic stethoscope
Model / Ref / Catalog
COR500, CAC500_BLK, CAC500_FSG, CAC500_FRP, CAC500_FBL, CAC500_FOW, CAC500_PRP, CAC500_ROG, CAC500_GRN, CAC500_FRB, CAC500_FEL, CAC500_FCB, CAC500_FBY, CAC500_CHP, CAC500_FMA, CAC500_FOT, CAC500_RED, CAC500_FGR, CORE 500, E8
Primary DI / UDI-DI
00850010298450, 00850010298771, 00850079955028, 00850010298245, 00850010298924, 00850010298672, 00850010298962, 00850010298597, 00850010298306, 00850010298917, 00850079955004, 00850079955011, 00850010298429, 00850010298269, 00850079955035, 00850010298733, 00850010298252, 00810209880026, 00810209880019, 00810209880002
Basic UDI-DI
0085001029COR500F2, 0850010298COR500MG
510(k) Number
FDA Product Code
DQD, DPS
EMDN Code
C9005 Phonendoscopes and stethoscopes
GMDN Term
Electronic acoustic stethoscope
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1875, 870.2340
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
CAC500_BLK
CAC500_FSG
CAC500_FRP
CAC500_FBL
CAC500_FOW
CAC500_PRP
CAC500_ROG
CAC500_GRN
CAC500_FRB
CAC500_FEL
CAC500_FCB
CAC500_FBY
CAC500_CHP
CAC500_FMA
CAC500_FOT
CAC500_RED
CAC500_FGR
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

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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