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Fully Automatic IHC Stainer

by Shenzhen Dartmon Biotechnology Co., Ltd. China EUDAMED

Ref AS360Model AS300

EMDN W0202059002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697550352AS300SERMT Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
AS300, AS360
Primary DI / UDI-DI
06927210914429
Basic UDI-DI
697550352AS300SERMT
Direct Marketing DI
06927210914429
EMDN Code
W0202059002 Automated slide stainers
Device Class
Class A
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000019183
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from Shenzhen Dartmon Biotechnology Co., Ltd.

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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 06927210914429|697550352AS300SERMT 61 fields · synced 24 Oct 2026