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Respiratory Virus Panel (7) Real Time PCR Kit

EUDAMED

Class IVD General (EU MDR)

Ref JC150701NW-24T

by Jiangsu Bioperfectus Technologies Co., Ltd.

Identity

Trade Name
Respiratory Virus Panel (7) Real Time PCR Kit EUDAMED
Device Name
Respiratory Virus Panel (7) Real Time PCR Kit EUDAMED
Model / Reference
JC150701NW-24T EUDAMED

Identifiers

Primary DI / UDI-DI
D-JC150701NW-24TL2 EUDAMED
Basic UDI-DI
B-JC150701NW-24TL2 EUDAMED
EMDN Code
W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - 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

Yes

EUDAMED

Microbial Substances

Yes

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

Respiratory Virus Panel (7) Real Time PCR Kit by Jiangsu Bioperfectus Technologies Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
CN-MF-000014691
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

  • EUDAMED 1ac2606f-9f8d-423e-a0b4-ed5ac706b4af 61 fields · synced Jun 20, 2026