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Malaria P.f./P.v. Rapid Test

by Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd. EUDAMED

Active European Union

Ref MALAC1-02

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-MALAC1-023G Basic UDI-DIDate30 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
MALAC1-02
Primary DI / UDI-DI
D-MALAC1-023G
Basic UDI-DI
B-MALAC1-023G
EMDN Code
W0105090401 Plasmodium (malaria) - rt & poc
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000020377
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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