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Precise Weak Anti-D

by Lorne Laboratories Ltd EUDAMED

Active European Union

Ref 209005Model Rare Phenotype Antibody Reagents

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060168050090 Basic UDI-DIDate5 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
Rare Phenotype Antibody Reagents, 209005
Primary DI / UDI-DI
05060168050090
Basic UDI-DI
B-05060168050090
EMDN Code
W0103030499 Immunohaematology controls - other
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

  • 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