← Back to catalogue

Real-Time PCR Detection Kit for Universal Plasmodium Falciparum

EUDAMED

Class IVD General (EU MDR)

Ref A3751Ref ID045

by Beijing Applied Biological Technologies Co., Ltd.

Identity

Device Name
Real-Time PCR Detection Kit for Universal Plasmodium Falciparum EUDAMED
Real-time PCR Detection Kit for Plasmodium Falciparum EUDAMED
Model / Reference
A3751 EUDAMED
ID045 EUDAMED

Identifiers

Primary DI / UDI-DI
06974323011156 EUDAMED
06974323011163 EUDAMED
06974323010982 EUDAMED
06974323010975 EUDAMED
Basic UDI-DI
B-06974323011156 EUDAMED
B-06974323011163 EUDAMED
B-06974323010982 EUDAMED
B-06974323010975 EUDAMED
EMDN Code
W0105050209 PLASMODIUM (MALARIA) EUDAMED
W0104050202 PLASMODIUM FALCIPARUM EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Real-Time PCR Detection Kit for Universal Plasmodium Falciparum by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Beijing Applied Biological Technologies Co., Ltd.
EUDAMED SRN
CN-MF-000012338
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (4)

  • EUDAMED f5e646e9-ba5a-4f49-82e1-32491536afe4 61 fields · synced Jul 22, 2026
  • EUDAMED 1e8e8879-13a3-4c84-abc0-c0a1546b1f2b 61 fields · synced May 19, 2026
  • EUDAMED 6d528b7f-2124-4128-b22b-7b1f3d31e23b 61 fields · synced Jul 22, 2026
  • EUDAMED 483cadc3-1725-4545-84f1-cfca01a9d51b 61 fields · synced Jul 22, 2026