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ISOSLIDE™ AFB Control Slides with reference tissue for the detection of acid-fast bacteria in histological tissue

by Merck KGaA Germany EUDAMED

Ref 1025600001 EMDN W010399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4027269102560UD Basic UDI-DIDate1 Jun 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  • Withdrawn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

Model / Reference
1025600001
Primary DI / UDI-DI
04027269862893
Basic UDI-DI
4027269102560UD
EMDN Code
W010399 Haematology / haemostasis / immunohaematology / histology / cytology reagents - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000018777

Other devices from Merck KGaA

See all devices from Merck KGaA →

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 f0bcff06-9b14-4b19-ab69-40b6c3f2c387 61 fields · synced 25 Oct 2026