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TECO® Fast Candida Mannan Antigen Lateral Flow Assay

by TECOmedical AG Switzerland EUDAMED

Ref TE1081 EMDN W0105060302

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07640146270146 Basic UDI-DIDate27 Dec 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  • Withdrawn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

Device Name
TECO® Fast Candida Mannan Antigen Lateral Flow Assay
Model / Reference
TE1081
Primary DI / UDI-DI
07640146270146
Basic UDI-DI
B-07640146270146
EMDN Code
W0105060302 Candida albicans
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000030341
Authorised representative
EUROBIO SCIENTIFIC FR-AR-000023178

Other devices from TECOmedical AG

See all devices from TECOmedical AG →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • 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

Sources (1)

  • EUDAMED f56fb207-ae0b-4571-bdfc-f51c8e64d398 61 fields · synced 22 Oct 2026