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Forwarts Wrattenverwijderaar

by Pronova Laboratories BV Netherlands EUDAMED510(k)

Ref FW10NL100Model FW10XX100 EMDN V0999

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number2260052CE01 Date21 Oct 2026IssuedStatusActive expires 1 Dec 2028
United StatesFDA 510(k) 510(k) NumberK201366 Date21 Jan 2021IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2260052CE01 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    21 Oct 2026
    Expires
    1 Dec 2028
    Reason
    Change approved

Specification

EUDAMED · 510(k) · synced 25 Oct 2026

Device Name
Forwarts Wart Remover
Model / Reference
FW10XX100, FW10NL100
Primary DI / UDI-DI
08717344390170
Basic UDI-DI
871734439FW10XXJ9
Direct Marketing DI
08717344390170
EMDN Code
V0999 Fluids/gases for clinical/therapeutical use - other
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000001486

From the manufacturer

Manufacturer's product page: Forwarts Wrattenverwijderaar

Other devices from Pronova Laboratories BV

See all devices from Pronova Laboratories BV →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED ea35fbee-c286-45de-b23d-ad1b277d2a7f 61 fields · synced 25 Oct 2026
  • FDA 510(k) K201366 1 fields · synced 18 May 2026