Skip to content

Monoclonal Rh Control

by Lorne Laboratories Ltd United Kingdom EUDAMED

Ref 640010Model Rhesus Monoclonal Antibody Reagents

EMDN W0103030499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060168051158 Basic UDI-DIDate2 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

Model / Reference
Rhesus Monoclonal Antibody Reagents, 640010
Primary DI / UDI-DI
05060168051158
Basic UDI-DI
B-05060168051158
EMDN Code
W0103030499 Immunohaematology controls - other
Device Class
Class IVD Annex II List A
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
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 05060168051158|B-05060168051158 61 fields · synced 24 Oct 2026