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Laborant Total Nucleic Acid Extraction Kit (96)

by Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

Ref LE-01-96

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8683808252080CG Basic UDI-DI 08683808252080UDI-DIDate12 May 2023RegisteredStatusActive

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  • Withdrawn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
LE-01-96
Primary DI / UDI-DI
08683808252080
Basic UDI-DI
8683808252080CG
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000033765

Other devices from Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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