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Automated Bacterial DNA Extraction Kit

by Vİsi̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

Ref VIS100229

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number86853424VIS100229B7 Basic UDI-DI 08685342400316UDI-DIDate20 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

EU market availability

Made available in 32 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 26 Apr 2022
  • Belgium since 26 Apr 2022
  • Bulgaria since 26 Apr 2022
  • Croatia since 26 Apr 2022
  • Cyprus since 26 Apr 2022
  • Czechia since 26 Apr 2022
  • Denmark since 26 Apr 2022
  • Estonia since 26 Apr 2022
  • Finland since 26 Apr 2022
  • France since 26 Apr 2022
  • Germany since 26 Apr 2022
  • Greece since 26 Apr 2022
  • Hungary since 26 Apr 2022
  • Iceland since 26 Apr 2022
  • Ireland since 26 Apr 2022
  • Italy since 26 Apr 2022
  • Latvia since 26 Apr 2022
  • Liechtenstein since 26 Apr 2022
  • Lithuania since 26 Apr 2022
  • Luxembourg since 26 Apr 2022
  • Malta since 26 Apr 2022
  • Netherlands since 26 Apr 2022
  • Northern Ireland since 26 Apr 2022
  • Norway since 26 Apr 2022
  • Poland since 26 Apr 2022
  • Portugal since 26 Apr 2022
  • Romania since 26 Apr 2022
  • Slovakia since 26 Apr 2022
  • Slovenia since 26 Apr 2022
  • Spain since 26 Apr 2022
  • Sweden since 26 Apr 2022
  • Türkiye since 26 Apr 2022

Last checked 23 Oct 2026.

Specification

EUDAMED

Model / Reference
VIS100229
Primary DI / UDI-DI
08685342400316
Basic UDI-DI
86853424VIS100229B7
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000024208

Other devices from Vİsi̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Vİsi̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

  • Professional Testing

Other properties (10)

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