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Anti-PLAP (Placental Alkaline Phosphatase)

by DB Biotech, a.s. 6 variants

Ref DB 047-0.5Model DB 047

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Overview

This device is a medical diagnostic tool designed to measure placental alkaline phosphatase (PLAP) levels in human tissues. It is used for various clinical applications, including prenatal testing and monitoring of fetal development.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number85850389DB047L6 Basic UDI-DI 08585038900819UDI-DIDate24 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
DB 047, DB 047-0.5
Primary DI / UDI-DI
08585038900819
Basic UDI-DI
85850389DB047L6
EMDN Code
W01030705 Fixing reagents (histology/cytology)
Device Class
Class C
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000051838

Other devices from DB Biotech, a.s.

See all devices from DB Biotech, a.s. →

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