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PeliClass human IgG subclass Plus kit

by Sanquin Reagents B.V. EUDAMED

Active European Union

Ref M1895

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-18720682030148 Basic UDI-DIDate3 Sep 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-18720682030148 Basic UDI-DIDate3 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, 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
PeliClass human IgG subclass Plus kit
Model / Reference
M1895
Primary DI / UDI-DI
18720682030148
Basic UDI-DI
B-18720682030148, 872068203M18954J
Direct Marketing DI
18720682030148
EMDN Code
W0102010106 Immunoglobulin g subclass reagents
Device Class
Class IVD General
Class B
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000530

Other devices from Sanquin Reagents B.V.

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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