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HISTO SPOT® AB Reagent Kit

by BAG Diagnostics GmbH Germany EUDAMED

Ref 728198 EMDN W010399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426022489HSAB04BAES Basic UDI-DIDate8 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
HISTO SPOT® AB Reagent Kit
Model / Reference
728198
Primary DI / UDI-DI
04260224891501
Basic UDI-DI
426022489HSAB04BAES
Direct Marketing DI
04260224891501
EMDN Code
W010399 Haematology / haemostasis / immunohaematology / histology / cytology reagents - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000024383

Other devices from BAG Diagnostics GmbH

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 849f8ee7-48d4-489b-a303-3fdd69682f87 61 fields · synced 25 Oct 2026