Skip to content

Staph Test Kit

by Lorne Laboratories Ltd United Kingdom EUDAMED

Ref 870100Model Rapid Agglutination Latex Kits

EMDN W0104080303

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060168050083 Basic UDI-DIDate6 Sep 2026RegisteredStatusActive

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

Device Name
Staph Test Kit - 100 Test kit
Model / Reference
Rapid Agglutination Latex Kits, 870100
Primary DI / UDI-DI
05060168050083
Basic UDI-DI
B-05060168050083
EMDN Code
W0104080303 Staphylococci slide tests
Device Class
Class IVD General
Market of Registration
Malta

Manufacturer details

EUDAMED SRN
GB-MF-000029354
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Lorne Laboratories Ltd

See all devices from Lorne Laboratories Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 05060168050083|B-05060168050083 61 fields · synced 24 Oct 2026