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Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref 10210105BModel 50 tests/kit
Identity
- Device Name
- Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMED10210105B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795550559 EUDAMED
- Basic UDI-DI
- B-06974795550559 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
Multiple 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-06974795550559 | 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 fbeed875-23da-412d-acb9-1ba4c1b2c537 61 fields · synced Jun 18, 2026