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One Step LH Ovulation Test (Colloidal Gold)

by Nantong Diagnos Biotechnology Co., Ltd. 3 variants

Ref LHCS15, LHCS50, LHCM01, LHCM02, LHCC40, LHCC25, LHCC01, LHCM25Model Strip（15tests/box）, Strip（50tests/box）, Midstream（1test/box）, Midstream（2tests/box）, Cassette（40tests/box）, Cassette（25tests/box）, Cassette（1test/box）, Midstream（25tests/box）

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06934592100715 Basic UDI-DI Date15 May 2025RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
Strip（15tests/box）, LHCS15, Strip（50tests/box）, LHCS50, Midstream（1test/box）, LHCM01, Midstream（2tests/box）, LHCM02, Cassette（40tests/box）, LHCC40, Cassette（25tests/box）, LHCC25, Cassette（1test/box）, LHCC01, Midstream（25tests/box）, LHCM25
Primary DI / UDI-DI
06934592100715, 06934592100463, 06934592100609, 06934592100616, 06934592100593, 06934592100586, 06934592100487, 06934592100708
Basic UDI-DI
B-06934592100715, B-06934592100463, B-06934592100609, B-06934592100616, B-06934592100593, B-06934592100586, B-06934592100487, B-06934592100708
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