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One-Step FSH Menopause Test

by Shanghai Chemtron Biotech Co., Ltd. EUDAMED

Active European Union

Ref 6003C 6003S 6003D 6003BModel Strip, Cassette, Midstream and Urine Cup

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CNM0000180726003N4 Basic UDI-DIDate25 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
One-Step FSH Menopause Test
Model / Reference
Strip, Cassette, Midstream and Urine Cup, 6003C 6003S 6003D 6003B
Primary DI / UDI-DI
D-CNM0000180726003N4
Basic UDI-DI
B-CNM0000180726003N4
EMDN Code
W0102160301 Fsh - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000018072
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

Show properties
  • Animal Tissues
  • Microbial Substances
  • Self Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No