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Capilia TB-Neo 100T/Box

by TAUNS Laboratories, Inc. EUDAMED

Active European Union

Ref CATB0870

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4987815TB019Z Basic UDI-DIDate17 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Capilia TB-Neo
Model / Reference
CATB0870
Primary DI / UDI-DI
04987815008703
Basic UDI-DI
4987815TB019Z
EMDN Code
W0105090199 Bacteriology - rt & poc - other
Device Class
Class C
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
JP-MF-000007041
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • 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