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SLHR010E

by Sugentech, Inc. South Korea EUDAMED

Ref SLHR010EModel Surearly SMART Ovulation Hormone Test

EMDN W0102050199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88094088SLHR-001AC Basic UDI-DIDate4 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Surearly SMART Ovulation Hormone Test, SLHR010E
Primary DI / UDI-DI
08809408862812
Basic UDI-DI
88094088SLHR-001AC
Direct Marketing DI
08809408862812
EMDN Code
W0102050199 Fertility function hormones - other
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000023952
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sugentech, Inc.

See all devices from Sugentech, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Self Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08809408862812|88094088SLHR-001AC 61 fields · synced 24 Oct 2026