Skip to content

Anti-D Monoclonal (lgG+lgM)

by Rapid Labs Ltd EUDAMED

Active European Union

Ref BG-D10Model Monoclonal

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-5060599400358X2 Basic UDI-DIDate9 Sep 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Monoclonal, BG-D10
Primary DI / UDI-DI
5060599400358X2
Basic UDI-DI
B-5060599400358X2
EMDN Code
W0103030102 Abo sera
Device Class
Class IVD Annex II List A
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
GB-MF-000026335
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Rapid Labs Ltd

See all devices from Rapid Labs Ltd →

Properties

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