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Duplex Real-Time PCR Detection Kit for Mycoplasma Pneumoniae and Bordetella Per…

EUDAMED

Class IVD General (EU MDR)

Ref CT8122-24TRef CT8122-48TRef ID005

by Beijing Applied Biological Technologies Co., Ltd.

Identity

Device Name
Duplex Real-Time PCR Detection Kit for Mycoplasma Pneumoniae and Bordetella Pertussis EUDAMED
Duplex Real-Time PCR Detection Kit for Mycoplasma pneumoniae and Legionella pneumophila EUDAMED
Model / Reference
CT8122-24T EUDAMED
CT8122-48T EUDAMED
ID005 EUDAMED

Identifiers

Primary DI / UDI-DI
06974323012153 EUDAMED
06974323012160 EUDAMED
06974323012672 EUDAMED
Basic UDI-DI
B-06974323012153 EUDAMED
B-06974323012160 EUDAMED
B-06974323012672 EUDAMED
EMDN Code
W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS 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

Duplex Real-Time PCR Detection Kit for Mycoplasma Pneumoniae and Bordetella Per… by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

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

Sources (3)

  • EUDAMED 8ba041c5-6fe5-4682-b8de-74352d247f46 61 fields · synced Jul 22, 2026
  • EUDAMED 70178293-ef66-4487-9748-8e0166dd2f1d 61 fields · synced May 19, 2026
  • EUDAMED 4c173f89-ceb5-4dab-9e0c-f24c12ee6429 61 fields · synced Jun 20, 2026