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Automatic Hematology Analyzer DD-5 Fluorescent Dye A

by Maccura Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref BL2201007Model 42 mL×1; 42 mL×3

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174BL2200076U Basic UDI-DIDate13 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
42 mL×1, 42 mL×3, BL2201007
Primary DI / UDI-DI
06950617415312
Basic UDI-DI
69506174BL2200076U
Direct Marketing DI
06950617415312
EMDN Code
W0103010199 Reagents for (automated) haematology analyzer - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Humiss International B.V. NL-AR-000001490

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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