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Chiwell

by Ningbo Chiwell Biotechnology Co., Ltd China EUDAMED

Ref E3+P3Model CW-1000+CW-800,E2+P8, E3+P3, E5+P5, E9+P9, A8+P8, A4+P4,E1, E4, E2, E3, E6,E7,E8,A1,A2,A3,A4,A5,A6,A7,A9,HE- 800,HE-820,HE-860,HE-890,HE-1000,HE-1200,HE- 1600,HE－1800

EMDN W0202059017

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697920376SSCS0014U Basic UDI-DIDate15 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Slide staining and cover slipping combination system
Model / Reference
CW-1000+CW-800, E2+P8, E3+P3, E5+P5, E9+P9, A8+P8, A4+P4, E1, E4, E2, E3, E6, E7, E8, A1, A2, A3, A4, A5, A6, A7, A9, HE- 800, HE-820, HE-860, HE-890, HE-1000, HE-1200, HE- 1600, HE－1800
Primary DI / UDI-DI
06979203760452
Basic UDI-DI
697920376SSCS0014U
Direct Marketing DI
06979203760452
EMDN Code
W0202059017 Cassette / slide printers
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 04940fdb-68ec-4276-aacb-f04540c59c8d 61 fields · synced 22 Oct 2026