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2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref CD312-02
Identity
- Trade Name
- 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit EUDAMED
- Device Name
- 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit EUDAMED
- Model / Reference
- CD312-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315737975 EUDAMED
- Basic UDI-DI
- B-06973315737975 EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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
2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit by Nanjing Vazyme Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06973315737975 | 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 (1)
- EUDAMED 1ebce6ad-4d7a-40c9-ac1b-b37d13b578f4 61 fields · synced Oct 9, 2026