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p16INK4a

by Zeta Corporation 12 variants

Ref Z2567MLModel JC2

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 24 Oct 2026. What this means

Overview

The p16INK4a device is a medical device used in dermatology, specifically for the diagnosis and treatment of melanoma. This device features an implantable electrode array with built-in temperature sensors, allowing for accurate thermal mapping and real-time data analysis. The p16INK4a has received regulatory clearance from several countries, including the United States, indicating its safety and efficacy for use in medical settings.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00840140711141 Basic UDI-DI 00840140711141UDI-DIDate1 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  • Withdrawn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

Model / Reference
JC2, Z2567ML
Primary DI / UDI-DI
00840140711141
Basic UDI-DI
B-00840140711141
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