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Six Respiratory Viruses Nucleic Acid Detection Kit (PCR-Melting Curve Method)
EUDAMEDClass IVD General (EU MDR)
Ref 32 tests/kitRef 96 tests/kit (A)
Identity
- Device Name
- Six Respiratory Viruses Nucleic Acid Detection Kit (PCR-Melting Curve Method) EUDAMED
- Model / Reference
- 32 tests/kit EUDAMED96 tests/kit (A) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972221450794 EUDAMED06972221450817 EUDAMED
- Basic UDI-DI
- B-06972221450794 EUDAMEDB-06972221450817 EUDAMED
- EMDN Code
- W01050499 VIROLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Six Respiratory Viruses Nucleic Acid Detection Kit (PCR-Melting Curve Method) by CapitalBio Technology (Chengdu) Co., Ltd. — Class IVD General — IVDD — listed…
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-06972221450794 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- CapitalBio Technology (Chengdu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000027694
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED aff54ccd-85e0-4b9d-8856-c6a6eec3c937 61 fields · synced Jul 22, 2026
- EUDAMED bf1620b8-911b-46a2-9d2e-7b99893cd5c8 61 fields · synced May 18, 2026