Skip to content

Sperm DNA Fragmentation Assay Kit（Flow Cytometry）（50 tests/kit）

by Chengdu Legend-Tec Technology Co., Ltd EUDAMED

Active European Union

Ref 201Model 20 tests/kit；50 tests/kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697735700200LY Basic UDI-DIDate8 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sperm DNA Fragmentation Assay Kit（Flow Cytometry）
Model / Reference
20 tests/kit；50 tests/kit, 201
Primary DI / UDI-DI
06977357002015
Basic UDI-DI
697735700200LY
EMDN Code
W02020499 Flow cytometry instruments - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000047100
Authorised representative
GRZAN GROUP SL ES-AR-000039086

Other devices from Chengdu Legend-Tec Technology Co., Ltd

See all devices from Chengdu Legend-Tec Technology Co., Ltd →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No