Skip to content

ECG cable compatible with Fukuda Denshi, snap 10 leads complete

by Biogenesis EUDAMED

Active European Union

Ref BIOECG.FU.S10F

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7730793BIOECGWX Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Electrocardiogram (ECG-EKG) – BIOECG
Model / Reference
BIOECG.FU.S10F
Primary DI / UDI-DI
07730793002792
Basic UDI-DI
7730793BIOECGWX
EMDN Code
C020599 Cardiac diagnostic devices - other
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
UY-MF-000002444
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Biogenesis

See all devices from Biogenesis →

Properties

Other properties (13)

  • Sterile: 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