Skip to content

Biom 7.8

by EKOVUK MEDI, s.r.o. Czech Republic EUDAMED

Ref BIOM 7.8Model 7.8

EMDN Z12099001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2026-MDR/QS-020 Date21 Apr 2026IssuedStatusActive expires 21 Apr 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-020 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    21 Apr 2026
    Expires
    21 Apr 2031

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
7.8, BIOM 7.8
Primary DI / UDI-DI
08594212440164
Basic UDI-DI
859421244BIOMHL
Direct Marketing DI
08594212440164
EMDN Code
Z12099001 Body impedance analysers
Device Class
Class IIa
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000040403

Other devices from EKOVUK MEDI, s.r.o.

See all devices from EKOVUK MEDI, s.r.o. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 1abfb529-5bf9-46db-ab83-5144a5009f94 61 fields · synced 22 Oct 2026