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Five Infectious Diarrhea Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe Met…
EUDAMEDClass IVD General (EU MDR)
Ref 10200145AModel 10 tests/kitRef 10200145BModel 50 tests/kit
Identity
- Device Name
- Five Infectious Diarrhea Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) EUDAMED
- Model / Reference
- 10 tests/kit EUDAMED10200145A EUDAMED50 tests/kit EUDAMED10200145B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795550399 EUDAMED06974795550382 EUDAMED
- Basic UDI-DI
- B-06974795550399 EUDAMEDB-06974795550382 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 Infectious Diarrhea Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe Met… 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-06974795550399 | 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 780d193d-34c0-44fb-b2c8-4f5a125bf015 61 fields · synced Jul 23, 2026
- EUDAMED 5bc0b992-8b92-4364-93ee-50e1adf4ca79 61 fields · synced May 19, 2026