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Chiwell

by Ningbo Chiwell Biotechnology Co., Ltd China EUDAMEDGUDID

Ref HE-1800, E2, HE-1600, E3, A1, CW-400, E7, E4, CW-420, A2, CW-820, CW-800, HE-820, E6, E2+P8, A5, HE-1000, A6, E9+P9, CW-180, A3, HE-1200Model 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, 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, CW-180、CW-360、CW-400、CW-400A、CW-400B、CW-420、CW-420A、CW-800、CW-820、CW-860、CW-880

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 Number06979203760728 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
Slide staining and cover slipping combination system
all-in-one automatic slide stainer&cover-slipper
Automatic 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, HE-1800, HE-800, HE-1600, CW-180、CW-360、CW-400、CW-400A、CW-400B、CW-420、CW-420A、CW-800、CW-820、CW-860、CW-880, CW-400, CW-420, CW-820, CW-800, CW-180
Primary DI / UDI-DI
06979203760728 EUDAMED
06979203760520 EUDAMED
06979203760711 EUDAMED
06979203760537 EUDAMED
06979203760575 EUDAMED
06979203760346 EUDAMED
06979203760551 EUDAMED
06979203760513 EUDAMED
06979203760377 EUDAMED
06979203760582 EUDAMED
06979203760407 EUDAMED
06979203760391 EUDAMED
06979203760667 EUDAMED
06979203760544 EUDAMED
06979203760445 EUDAMED
06979203760612 EUDAMED
06979203760698 EUDAMED
06979203760629 EUDAMED
06979203760476 EUDAMED
06979203760322 EUDAMED
06979203760599 EUDAMED
06979203760704 EUDAMED
06979203760056 GUDID
Basic UDI-DI
697920376SSCS0014U, 697920376ACS001FR
Direct Marketing DI
06979203760728
06979203760520
06979203760711
06979203760537
06979203760575
06979203760346
06979203760551
06979203760513
06979203760377
06979203760582
06979203760407
06979203760391
06979203760667
06979203760544
06979203760445
06979203760612
06979203760698
06979203760629
06979203760476
06979203760322
06979203760599
06979203760704
FDA Product Code
LXG
EMDN Code
W0202059017, W0202059008
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
06979203760728
06979203760520
06979203760711
06979203760537
06979203760575
06979203760346
06979203760551
06979203760513
06979203760377
06979203760582
06979203760407
06979203760391
06979203760667
06979203760544
06979203760445
06979203760612
06979203760698
06979203760629
06979203760476
06979203760322
06979203760599
06979203760704
GUDID
06979203760056
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 (23)

  • EUDAMED a0be00ca-e9dc-46f8-8817-d49f43ac92f3 61 fields · synced 22 Oct 2026
  • EUDAMED 06979203760520|697920376SSCS0014U 61 fields · synced 16 May 2026
  • EUDAMED 06979203760711|697920376SSCS0014U 61 fields · synced 16 May 2026
  • EUDAMED 06979203760537|697920376SSCS0014U 61 fields · synced 16 May 2026
  • EUDAMED 06979203760575|697920376SSCS0014U 61 fields · synced 16 May 2026
  • EUDAMED 06979203760346|697920376ACS001FR 61 fields · synced 16 May 2026
  • EUDAMED 06979203760551|697920376SSCS0014U 61 fields · synced 16 May 2026
  • EUDAMED 06979203760513|697920376SSCS0014U 61 fields · synced 17 May 2026
  • EUDAMED 06979203760377|697920376ACS001FR 61 fields · synced 17 May 2026
  • EUDAMED 06979203760582|697920376SSCS0014U 61 fields · synced 17 May 2026
  • EUDAMED 06979203760407|697920376ACS001FR 61 fields · synced 17 May 2026
  • EUDAMED 06979203760391|697920376ACS001FR 61 fields · synced 18 May 2026
  • EUDAMED 06979203760667|697920376SSCS0014U 61 fields · synced 18 May 2026
  • EUDAMED 06979203760544|697920376SSCS0014U 61 fields · synced 18 May 2026
  • EUDAMED 06979203760445|697920376SSCS0014U 61 fields · synced 18 May 2026
  • EUDAMED 06979203760612|697920376SSCS0014U 61 fields · synced 18 May 2026
  • EUDAMED 06979203760698|697920376SSCS0014U 61 fields · synced 18 May 2026
  • EUDAMED 06979203760629|697920376SSCS0014U 61 fields · synced 18 May 2026
  • EUDAMED 06979203760476|697920376SSCS0014U 61 fields · synced 18 May 2026
  • EUDAMED 06979203760322|697920376ACS001FR 61 fields · synced 18 May 2026
  • EUDAMED 06979203760599|697920376SSCS0014U 61 fields · synced 19 May 2026
  • EUDAMED 06979203760704|697920376SSCS0014U 61 fields · synced 19 May 2026
  • FDA UDI a39448e5-32b7-4fac-bc7b-319e1f956acd 32 fields · synced 22 Oct 2026