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Histology Reagents - Other

by ScyTek Laboratories Inc. 59 variants

Ref EZB500

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 Number081010871W01030799GD Basic UDI-DI 00810108715542UDI-DIDate13 May 2022RegisteredStatusActive

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  • Withdrawn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
Histology Reagents - Other
Model / Reference
EZB500
Primary DI / UDI-DI
00810108715542
Basic UDI-DI
081010871W01030799GD
Direct Marketing DI
00810108715542
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000023816
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from ScyTek Laboratories Inc.

See all devices from ScyTek Laboratories Inc. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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