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SmarLumi

by Guangzhou Wondfo Biotech Co., Ltd. China EUDAMED

Ref W859P0005

EMDN W0102152011

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06933289858434 Basic UDI-DIDate17 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Inflammation Quality Controls
Model / Reference
W859P0005
Primary DI / UDI-DI
06933289858434
Basic UDI-DI
B-06933289858434
EMDN Code
W0102152011 Controls for autoimmunity
Device Class
Class IVD General
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000000689
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Guangzhou Wondfo Biotech Co., Ltd.

See all devices from Guangzhou Wondfo Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06933289858434|B-06933289858434 61 fields · synced 25 Oct 2026