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Flu A & B Rapid Test Kit

by Triplex International Biosciences (China) Co., LTD. China EUDAMED

Ref C011928Model 25 tests/ kit

EMDN W0105099004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06950917930300 Basic UDI-DIDate21 Oct 2022RegisteredStatusActive

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 22 Oct 2026

Device Name
Flu A & B Rapid Test Kit
Model / Reference
25 tests/ kit, C011928
Primary DI / UDI-DI
06950917930300
Basic UDI-DI
B-06950917930300
EMDN Code
W0105099004 Influenza a and /or b - rt & poc
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000001097
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Triplex International Biosciences (China) Co., LTD.

See all devices from Triplex International Biosciences (China) 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 16722efb-f87a-405c-8cda-b74b6df62a87 61 fields · synced 22 Oct 2026