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Boditech Estradiol Calibrator

by Boditech Med Inc. South Korea EUDAMED

Ref CFPO-435Model Boditech Estradiol Calibrator

EMDN W0102152202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880613305059D7 Basic UDI-DIDate27 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
Boditech Estradiol Calibrator, CFPO-435
Primary DI / UDI-DI
08806133050590
Basic UDI-DI
880613305059D7
EMDN Code
W0102152202 Hormone standards and calibrators
Device Class
Class B
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
KR-MF-000011028
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Boditech Med, Inc.

See all devices from Boditech Med, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 08806133050590|880613305059D7 61 fields · synced 25 Oct 2026