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Leukocyte Α-Naphthyl Acetate (Non-Specific Esterase) Kit

by Sigma-Aldrich Corporation 2 variants

Ref 91A-1KTModel 91A-1KT and 91C-1KT

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number040618917Y Basic UDI-DI 04061833264577UDI-DIDate21 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Leukocyte α-Naphthyl Acetate (Non-Specific Esterase) and Leukocyte Naphthol AS-D Chloroacetate (Specific Esterase) Kit 91
Model / Reference
91A-1KT and 91C-1KT, 91A-1KT
Primary DI / UDI-DI
04061833264577
Basic UDI-DI
040618917Y
EMDN Code
W0103010301 Histo / cyto stains
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000025162
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Sigma-Aldrich Corporation

See all devices from Sigma-Aldrich Corporation →

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