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Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref CD502Ref S3105E
Identity
- Trade Name
- Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit EUDAMEDNovel Coronavirus (SARS-CoV-2) and Influenza A/B Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit EUDAMEDNovel Coronavirus (SARS-CoV-2) and Influenza A/B Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- CD502 EUDAMEDS3105E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315730341 EUDAMED06955792733237 EUDAMED
- Basic UDI-DI
- B-06973315730341 EUDAMEDB-06955792733237 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMEDW0105070502 OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit by Nanjing Vazyme Medical Technology Co., Ltd. — Class IVD General — IVDD…
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-06973315730341 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED d07bcc62-0e86-4d0d-851f-94b53385fd41 61 fields · synced Oct 7, 2026
- EUDAMED 0d86a595-c41a-4294-a9b1-000963057579 61 fields · synced May 18, 2026