Skip to content

Chiwell

by Ningbo Chiwell Biotechnology Co., Ltd China EUDAMED

Ref HD-400iModel CW-120、CW-600、CW-1000、HD-400i、HD-600i

EMDN W0202059002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697920376ASSUR Basic UDI-DIDate18 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

Device Name
Automatic Slide Stainer
Model / Reference
CW-120、CW-600、CW-1000、HD-400i、HD-600i, HD-400i
Primary DI / UDI-DI
06979203760780
Basic UDI-DI
697920376ASSUR
Direct Marketing DI
06979203760780
EMDN Code
W0202059002 Automated slide stainers
Device Class
Class A
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000034310
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Ningbo Chiwell Biotechnology Co., Ltd

See all devices from Ningbo Chiwell Biotechnology Co., Ltd →

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 06979203760780|697920376ASSUR 61 fields · synced 24 Oct 2026