StrongStep® SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit

EUDAMED

Class IVD General (EU MDR)

Ref 510010Model 96 Tests/box

by Nanjing Liming Bio-products Co. Ltd

Identity

Trade Name: StrongStep® SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit EUDAMED
Device Name: SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit EUDAMED
Model / Reference: 96 Tests/box EUDAMED
510010 EUDAMED

Identifiers

Primary DI / UDI-DI: 06973181850068 EUDAMED
Basic UDI-DI: B-06973181850068 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: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

StrongStep® SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit by Nanjing Liming Bio-products Co. Ltd — Class IVD General — IVDD — listed in EUDAMED

Manufacturer's product page: SARS-CoV-2 & Influenza A/B Multiplex Real-Time ...

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-06973181850068	Class IVD General	Active

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Manufacturer

Manufacturer: Nanjing Liming Bio-products Co. Ltd
EUDAMED SRN: CN-MF-000041298
Authorised Representative: Wellkang Ltd XI-AR-000001836

Sources (1)

EUDAMED 006017d3-f43a-4a67-95d7-2dc75be0ab96 61 fields · synced Jun 19, 2026