Skip to content

NamuPlex™

by SML Genetree Co., Ltd. 3 variants

Ref Q021A-100Model Q021A

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 Number880008792021GIB1PH Basic UDI-DI 08800087901496UDI-DIDate22 Jul 2025RegisteredStatusActive

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  • Withdrawn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™ GI Bacteria 1 Kit
Model / Reference
Q021A, Q021A-100
Primary DI / UDI-DI
08800087901496
Basic UDI-DI
880008792021GIB1PH
EMDN Code
W0105070504 Gastrointestinal 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