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Lysun

by Hangzhou Lysun Biotechnology Co., Ltd China EUDAMED

Ref RFM-201

EMDN W0201069099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697177120RFM201H2 Basic UDI-DIDate13 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Renal Function Analysis Meter
Model / Reference
RFM-201
Primary DI / UDI-DI
06971771200514
Basic UDI-DI
697177120RFM201H2
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000010254
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hangzhou Lysun Biotechnology Co., Ltd

See all devices from Hangzhou Lysun Biotechnology Co., Ltd →

Properties & raw data

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

Sources (1)

  • EUDAMED 06971771200514|697177120RFM201H2 61 fields · synced 24 Oct 2026