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Hemoglobin Analysis Meter

by Hangzhou Lysun Biotechnology Co., Ltd China EUDAMED

Ref 3993100101Model BHM-101

EMDN W02020680

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69717712090059P Basic UDI-DIDate30 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Hemoglobin Analysis Meter
Model / Reference
BHM-101, 3993100101
Primary DI / UDI-DI
D-69717712090059P
Basic UDI-DI
B-69717712090059P
EMDN Code
W02020680 Rapid test hematology / histology / cytology instruments - hardware accessories
Device Class
Class IVD General
Market of Registration
Germany

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 6bdff562-79fc-4460-a4a4-7ed0def9a5fc 61 fields · synced 22 Oct 2026