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Mycoplasma Pneumoniae Ab Hizli Test Ki̇ti̇

by Vİsi̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 2 variants

Ref VISV2207AGT061

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number868382945VISV2207AGT061FH Basic UDI-DI 08683829456306UDI-DIDate21 Oct 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  • Withdrawn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

Device Name
SARS-CoV-2 NEUTRALIZING ANTIBODY RAPID TEST KIT
Model / Reference
VISV2207AGT061
Primary DI / UDI-DI
08683829456306
Basic UDI-DI
868382945VISV2207AGT061FH
EMDN Code
W0105090502 Coronavirus antibody (ab) - rt & poc
Device Class
Class B
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