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Emicizumab Controls

by r2 Diagnostics Inc. United States EUDAMED

Ref 152-401

EMDN W0103020702

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00859394006248 Basic UDI-DIDate21 May 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
152-401
Primary DI / UDI-DI
00859394006248
Basic UDI-DI
B-00859394006248
EMDN Code
W0103020702 Control plasma for haemostasis
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000020735
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

From the manufacturer

Manufacturer's product page: Emicizumab Controls

Other devices from r2 Diagnostics Inc.

See all devices from r2 Diagnostics Inc. →

Properties & raw data

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

Sources (1)

  • EUDAMED dcbe6eb4-5a77-49df-ad82-7d4112c3087d 61 fields · synced 24 Oct 2026