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SmarLumi

by Guangzhou Wondfo Biotech Co., Ltd. China EUDAMED

Ref WA89P0003

EMDN W0105040307

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06933289859431 Basic UDI-DIDate10 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 24 Oct 2026

Device Name
Herpes simplex virus-1 lgM (CLIA)
Model / Reference
WA89P0003
Primary DI / UDI-DI
06933289859431
Basic UDI-DI
B-06933289859431
EMDN Code
W0105040307 Hsv 1 igm
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
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06933289859431|B-06933289859431 61 fields · synced 24 Oct 2026