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Microsporidia IFAT

by Bordier Affinity Products SA Switzerland EUDAMED

Ref 8100

EMDN W0104050299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07640158218105 Basic UDI-DIDate13 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 24 Oct 2026

Model / Reference
8100
Primary DI / UDI-DI
07640158218105
Basic UDI-DI
B-07640158218105, 7640158218100ZS
Direct Marketing DI
07640158218105
EMDN Code
W0104050299 Detection and identification (parasitology) - other
Device Class
Class IVD General
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
CH-MF-000025247
Authorised representative
Leman Diagnostics SARL FR-AR-000024185

Other devices from Bordier Affinity Products SA

See all devices from Bordier Affinity Products SA →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 86215436-81d0-4d16-a85b-b8db032ba913 61 fields · synced 24 Oct 2026
  • EUDAMED 07640158218105|7640158218100ZS 61 fields · synced 18 May 2026