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Five Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref 10210111AModel 10 tests/kitRef 10210111BModel 50 tests/kit
Identity
- Device Name
- Five Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method) EUDAMED
- Model / Reference
- 10 tests/kit EUDAMED10210111A EUDAMED50 tests/kit EUDAMED10210111B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795550306 EUDAMED06974795550313 EUDAMED
- Basic UDI-DI
- B-06974795550306 EUDAMEDB-06974795550313 EUDAMED
- EMDN Code
- W0105070201 GRAM+ - GRAM- - FUNGI - MULTIPLEX 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
Five Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR 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-06974795550306 | 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 4042b30e-5025-42d3-96c2-cc9811e8ce64 61 fields · synced Oct 6, 2026
- EUDAMED 01374391-3fc3-44e4-b44d-217aa2668727 61 fields · synced May 18, 2026