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Kit of 3 leads compatible with Nihon Kohden, clamp

by Biogenesis 2 variants

Ref BIOECG.NK.C3

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7730793BIOECGWX Basic UDI-DI 07730793004611UDI-DIDate5 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Electrocardiogram (ECG-EKG) – BIOECG
Model / Reference
BIOECG.NK.C3
Primary DI / UDI-DI
07730793004611
Basic UDI-DI
7730793BIOECGWX
EMDN Code
C020599 Cardiac diagnostic devices - other
Device Class
Class I
EU 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