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Loopamp™ Malaria Pan Detection Kit

by Eiken Chemical Co., Ltd. 2 variants

Ref 974000Model Loopamp™ Malaria Pan Detection Kit

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 Number4987026TD-LFMPZM Basic UDI-DI 04033145191407UDI-DIDate19 Dec 2022RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Loopamp™ Malaria Pan Detection Kit, 974000
Primary DI / UDI-DI
04033145191407
Basic UDI-DI
4987026TD-LFMPZM
EMDN Code
W0105050209 Plasmodium (malaria)
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000018097
Authorised representative
Human Gesellschaft für Biochemica und Diagnostica mbH DE-AR-000025586

Other devices from Eiken Chemical Co., Ltd.

See all devices from Eiken Chemical 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