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One Step LH Ovulation Test (Colloidal Gold)

by Nantong Diagnos Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref LHCS05Model Strip（5tests/box）

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06934592100401 Basic UDI-DIDate15 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
Strip（5tests/box）, LHCS05
Primary DI / UDI-DI
06934592100401
Basic UDI-DI
B-06934592100401
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000041526
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Nantong Diagnos Biotechnology Co., Ltd.

See all devices from Nantong Diagnos Biotechnology Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Self Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No