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Mr

by Mr International Healthcare Technology Co., Ltd. China EUDAMED

Ref EC9005Model HTSH-2000

EMDN W0201010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number489714646MR003JE Basic UDI-DIDate30 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Biochemistry Analyzer
Model / Reference
HTSH-2000, EC9005
Primary DI / UDI-DI
04897146460142
Basic UDI-DI
489714646MR003JE
Direct Marketing DI
04897146460142
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000047634
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
  • New Device
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 ee4aa64a-df7e-4fbe-9305-4f211cac31ad 61 fields · synced 24 Oct 2026