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SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)
EUDAMEDClass IVD General (EU MDR)
Ref 10210121AModel 10 tests/kitRef 10210121BModel 50 tests/kit
Identity
- Device Name
- SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) EUDAMED
- Model / Reference
- 10 tests/kit EUDAMED10210121A EUDAMED50 tests/kit EUDAMED10210121B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795550481 EUDAMED06974795550498 EUDAMED
- Basic UDI-DI
- B-06974795550481 EUDAMEDB-06974795550498 EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - NA REAGENTS 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
SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) by RocGene (Xuzhou) Technology Limited — 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-06974795550481 | 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 (2)
- EUDAMED e8abba66-effd-4d48-a654-21ffe228e79e 61 fields · synced Jul 20, 2026
- EUDAMED 95ac6acb-7e0f-470a-ae4b-78fb6e201951 61 fields · synced May 18, 2026