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Sperm ROS Staining Kit (Flow Cytometry)（20 tests/kit）

by Chengdu Legend-Tec Technology Co., Ltd China EUDAMED

Ref 204Model 20 tests/kit；50 tests/kit EMDN W02020499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697735700204M8 Basic UDI-DIDate15 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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Sperm ROS Staining Kit (Flow Cytometry)
Model / Reference
20 tests/kit；50 tests/kit, 204
Primary DI / UDI-DI
06977357002046
Basic UDI-DI
697735700204M8
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

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Professional Testing
Other properties (9)
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06977357002046|697735700204M8 61 fields · synced 25 Oct 2026