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Chiwell

by Ningbo Chiwell Biotechnology Co., Ltd China EUDAMEDGUDID

Ref CW-1000+CW-800Model 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

Product code LXGEMDN W0202059017

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number697920376SSCS0014U Basic UDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06979203760438 UDI-DIDate29 Dec 2025ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Chiwell EUDAMED
Chiwell Biotechnology GUDID
Generic Name
Microscope slide coverslipper IVD
Device Name
all-in-one automatic slide stainer&cover-slipper
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
06979203760438 EUDAMED
06979203760032 GUDID
Basic UDI-DI
697920376SSCS0014U
Direct Marketing DI
06979203760438
FDA Product Code
LXG
EMDN Code
W0202059017 Cassette / slide printers
GMDN Term
Microscope slide coverslipper IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2050
Market of Registration
Czechia
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06979203760438
GUDID
06979203760032
Device ClassEUDAMED
Class A
GUDID
Class I

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
  • Premarket Exempt
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (18)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No

Sources (2)

  • EUDAMED 761cc604-d3ab-4a4c-93eb-84579ad83bf7 61 fields · synced 22 Oct 2026
  • FDA UDI 86a329e9-2417-407e-a9cb-368cdfbd532e 32 fields · synced 22 Oct 2026