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CardioSphere

by eResearchTechnology GmbH 2 variants

Ref 151262

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04057155000696 UDI-DI Date22 Jul 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4057155Z12150101003C7 Basic UDI-DI 04057155000696UDI-DIDate10 May 2023RegisteredStatusActive

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 found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
CardioSphere EUDAMED
SpiroSphere GUDID
Generic Name
Electrocardiograph, professional, multichannel
Model / Reference
151262 EUDAMED
CardioSphere Standard GUDID
Primary DI / UDI-DI
04057155000696
Basic UDI-DI
4057155Z12150101003C7
510(k) Number
FDA Product Code
DPS
EMDN Code
C020599 Cardiac diagnostic devices - other
GMDN Term
Electrocardiograph, professional, multichannel
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2340
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
151262
GUDID
CardioSphere Standard
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000008015

Other devices from eResearchTechnology GmbH

See all devices from eResearchTechnology GmbH →

Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number

Other properties (21)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No