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2019-Novel Coronavirus(2019-nCoV) Triplex RT-qPCR Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref CD302-02
Identity
- Trade Name
- 2019-Novel Coronavirus(2019-nCoV) Triplex RT-qPCR Detection Kit EUDAMED2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit EUDAMED
- Device Name
- 2019-Novel Coronavirus(2019-nCoV) Triplex RT-qPCR Detection Kit EUDAMED2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit EUDAMED
- Model / Reference
- CD302-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739771 EUDAMED
- Basic UDI-DI
- B-06973315739771 EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - 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
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-06973315739771 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 5bc5e991-7406-4d01-a2df-7bfeba0ef699 61 fields · synced Oct 7, 2026
- EUDAMED 528eaa02-84f0-4b60-8b7b-2d79a47eae05 61 fields · synced Jun 19, 2026