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Five Respiratory Virus Nucleic Acid Test Kit (PCR Fluorescent Probe Method)
EUDAMEDClass IVD General (EU MDR)
Ref 10210122BModel 60 tests/kit
Identity
- Device Name
- Five Respiratory Virus Nucleic Acid Test Kit (PCR Fluorescent Probe Method) EUDAMED
- Model / Reference
- 60 tests/kit EUDAMED10210122B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795550610 EUDAMED
- Basic UDI-DI
- B-06974795550610 EUDAMED
- EMDN Code
- W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Five Respiratory Virus Nucleic Acid Test Kit (PCR Fluorescent Probe Method) by RocGene (Xuzhou) Technology Limited — Class IVD General — IVDD — listed in…
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-06974795550610 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- EUDAMED SRN
- CN-MF-000024511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 51297aff-ceb9-46c2-ab0c-ae7bd5b18c40 61 fields · synced Jul 9, 2026