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Gram Stain Kit

by Zhuhai Lituo Biotechnology Co., Ltd. China EUDAMED

Ref LTA080303Model Model Ⅰ, Model Ⅱ, Model Ⅲ, Model Ⅳ, Model Ⅴ

EMDN W01030702

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697223584GSKSG Basic UDI-DIDate24 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Model Ⅰ, Model Ⅱ, Model Ⅲ, Model Ⅳ, Model Ⅴ, LTA080303
Primary DI / UDI-DI
06972235844657
Basic UDI-DI
697223584GSKSG
EMDN Code
W01030702 Cytochemical staining reagents
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000026852
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhuhai Lituo Biotechnology Co., Ltd.

See all devices from Zhuhai Lituo Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 657195b7-dd0d-4d89-a846-e2f49ce7abf6 61 fields · synced 23 Oct 2026