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Renal Function Analysis Meter

by Hangzhou Lysun Biotechnology Co., Ltd China EUDAMED

Ref W02020680Model RFM-101

EMDN W02020680

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-6971771209036A2 Basic UDI-DIDate30 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Renal Function Analysis Meter
Model / Reference
RFM-101, W02020680
Primary DI / UDI-DI
D-6971771209036A2
Basic UDI-DI
B-6971771209036A2
EMDN Code
W02020680 Rapid test hematology / histology / cytology instruments - hardware accessories
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000010254
Authorised representative
Lotus NL B.V. NL-AR-000000121

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
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No

Sources (1)

  • EUDAMED 12b5516b-cf05-4ca6-8903-5285a460863c 61 fields · synced 22 Oct 2026