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Hemoglobin Control Solution

by Hangzhou Bosure Biotech Co., Ltd China EUDAMED

Ref BA-131-1Model HC-101

EMDN W0103010606

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06975519630595 Basic UDI-DIDate10 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

Model / Reference
HC-101, BA-131-1
Primary DI / UDI-DI
06975519630595
Basic UDI-DI
B-06975519630595
EMDN Code
W0103010606 Haematology controls - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000003001
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Hangzhou Bosure Biotech Co., Ltd

See all devices from Hangzhou Bosure Biotech Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED a17a5d2d-a498-4f02-a60b-786d64814650 61 fields · synced 22 Oct 2026