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Vis-Mag Extraction System

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

Ref VISMAG

Vis-Mag Extraction System (VISMAG) is a Class A device made by Vİsi̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 868382945VISMAG4H), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number868382945VISMAG4H Basic UDI-DI Date30 Oct 2026RegisteredStatusActive

Official records

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / reference
VISMAG
Primary DI / UDI-DI
08683829453169, 08683829459543
Basic UDI-DI
868382945VISMAG4H
EMDN code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
Device class
Class A
EU registration type
Standard device
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000024208

Similar devices in this category

Other devices filed under NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS.

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

  • Reagent
  • Professional testing
Other properties (11, all answered No)