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Automatic Hybrid Capture System

by Hangzhou Dalton BioSciences, Ltd. China EUDAMED

Ref HB-314CModel HB-104C

EMDN W0201020104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697387314HBCTQ Basic UDI-DIDate1 Aug 2025RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
HB-104C, HB-314C
Primary DI / UDI-DI
06973873149043
Basic UDI-DI
697387314HBCTQ
Direct Marketing DI
06973873149043
EMDN Code
W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
Device Class
Class A
Special Device Type
Software

Manufacturer details

EUDAMED SRN
CN-MF-000036196
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

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 03d28e74-006d-4b2f-9027-ee8009c4771b 61 fields · synced 24 Oct 2026