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NamuPlex™

by SML Genetree Co., Ltd. 3 variants

Ref GNT-2013-1

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88000879017SD Basic UDI-DI 08800087901014UDI-DIDate10 Jul 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  • Withdrawn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
NamuPlex™ Respiratory Pathogen Real-time PCR Kit
Model / Reference
GNT-2013-1
Primary DI / UDI-DI
08800087901014
Basic UDI-DI
88000879017SD
EMDN Code
W0105070503 Respiratory tract infections - multiplex na reagents
Device Class
Class C
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000034755
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sml Genetree Co. Ltd.

See all devices from Sml Genetree Co. Ltd. →

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