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SmarLumi

by Guangzhou Wondfo Biotech Co., Ltd. China EUDAMED

Ref A004P0006

EMDN W05039080

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69332898CE2812FV Basic UDI-DIDate22 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

Romania
  • Active
  • Not covered

European Union — CE/IVDR Active

EU market availability

Available in 1 country, as listed in EUDAMED:

  • Romaniasince 1 Jan 2026

Last checked 25 Oct 2026.

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Substrate Solution
Model / Reference
A004P0006
Primary DI / UDI-DI
06933289828123
Basic UDI-DI
69332898CE2812FV
Direct Marketing DI
06933289828123
EMDN Code
W05039080 Devices for samples analyses - other accessories
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000000689
Authorised representative
QbD RepS BV BE-AR-000000040

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
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06933289828123|69332898CE2812FV 61 fields · synced 25 Oct 2026