Skip to content

Fully Automatic IHC Stainer

by Shenzhen Dartmon Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref AS610 PLUSModel AS600

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697550352AS600SERP2 Basic UDI-DIDate23 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
AS600, AS610 PLUS
Primary DI / UDI-DI
06927210914559
Basic UDI-DI
697550352AS600SERP2
Direct Marketing DI
06927210914559
EMDN Code
W0202059002 Automated slide stainers
Device Class
Class A
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000019183
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Shenzhen Dartmon Biotechnology Co., Ltd.

See all devices from Shenzhen Dartmon Biotechnology Co., Ltd. →

Properties

  • 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