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CD3

by Diagnostic BioSystems EUDAMED

Active European Union

Ref RMAB005-01Model Primary Antibodies

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00846405009527 Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Primary Antibodies
Model / Reference
Primary Antibodies, RMAB005-01
Primary DI / UDI-DI
00846405009527
Basic UDI-DI
B-00846405009527
EMDN Code
W0102010105 Immunoglobulin g
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000028606
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from Diagnostic BioSystems

See all devices from Diagnostic BioSystems →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No