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One Step LH Ovulation Test

by Shanghai Chemtron Biotech Co., Ltd. China EUDAMED

Ref 6002C31SN20Model Strip, Cassette, Midstream

EMDN W0102160304

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number693869766002R6 Basic UDI-DIDate30 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
Strip, Cassette, Midstream, 6002C31SN20
Primary DI / UDI-DI
06977775222606
Basic UDI-DI
693869766002R6
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000018072
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Shanghai Chemtron Biotech Co., Ltd.

See all devices from Shanghai Chemtron Biotech Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 06977775222606|693869766002R6 61 fields · synced 25 Oct 2026