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VISION ESR Analyzer

by Shenzhen Yhlo Biotech Co., Ltd. United States EUDAMED

Ref V6108Model VISION-A

EMDN W02029001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-V6108U4 Basic UDI-DIDate16 Mar 2023RegisteredStatusActive

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 24 Oct 2026

Model / Reference
VISION-A, V6108
Primary DI / UDI-DI
D-V6108U4
Basic UDI-DI
B-V6108U4
EMDN Code
W02029001 Erythrocyte sedimentation rate devices
Device Class
Class IVD General
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000001137
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Yhlo Biotech Co., Ltd.

See all devices from Shenzhen Yhlo Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED c6bb9b96-a482-40dd-a555-e3f9115aee3b 61 fields · synced 24 Oct 2026