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Male factor infertility detection Kit

by Xiamen Biofast Biotechnology Co., Ltd. China EUDAMED

Ref 04110007 EMDN W0106010399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975358885309 Basic UDI-DIDate25 Oct 2022RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Male factor infertility detection Kit
Model / Reference
04110007
Primary DI / UDI-DI
06975358885309
Basic UDI-DI
B-06975358885309
EMDN Code
W0106010399 Chromosomal disorders tests - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000027220
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Xiamen Biofast Biotechnology Co., Ltd.

See all devices from Xiamen Biofast Biotechnology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 82716871-e25e-486e-9096-c03ba659860c 61 fields · synced 25 Oct 2026