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Cytokeratin 8/18

by Zeta Corporation 3 variants

Ref Z2435ML, Z2433MS, Z2435MS, Z2252MP, Z2435MP, Z2435MT, Z2252ML, Z2433MTModel ZM125, ZM123, B22.1 & B23.1

Active European Union

CE IVDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00840140705225 Basic UDI-DI Date1 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Trade Name
Cytokeratin 8/18
Cytokeratin 8
Model / Reference
ZM125, Z2435ML, ZM123, Z2433MS, Z2435MS, B22.1 & B23.1, Z2252MP, Z2435MP, Z2435MT, Z2252ML, Z2433MT
Primary DI / UDI-DI
00840140705225, 00840140705157, 00840140705232, 00840140705218, 00840140705256, 00840140705249, 00840140705188, 00840140705164
Basic UDI-DI
B-00840140705225, B-00840140705157, B-00840140705232, B-00840140705218, B-00840140705256, B-00840140705249, B-00840140705188, B-00840140705164
EMDN Code
W01030709 Primary antisera for immunohistology
Device Class
Class IVD General
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
US-MF-000008650
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Zeta Corporation

See all devices from Zeta 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