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Lyme IgG/IgM Rapid Test Cassette

by Hangzhou Alltest Biotech.Co., Ltd. China EUDAMED

Ref ILY-402 EMDN W0105010699,W0105090199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936983152891 Basic UDI-DIDate8 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
ILY-402
Primary DI / UDI-DI
06936983152891, 06936983140867, 06942598244036
Basic UDI-DI
B-06936983152891, B-06936983140867, B-06942598244036
EMDN Code
W0105010699,W0105090199, W0105090199
Device Class
Class IVD General
Market of Registration
Hungary
Lithuania
Latvia

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

See all devices from Hangzhou Alltest Biotech.Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent YesEUDAMEDNoEUDAMED
  • 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 (3)

  • EUDAMED 657c0e68-8648-4d13-b808-21a55aa6654e 61 fields · synced 22 Oct 2026
  • EUDAMED 06936983140867|B-06936983140867 61 fields · synced 19 May 2026
  • EUDAMED 06942598244036|B-06942598244036 61 fields · synced 9 Oct 2026