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Coxsackievirus A6/A10/A16 & Enterovirus 71 & Enterovirus Universal Nucleic Acid…
EUDAMEDClass IVD General (EU MDR)
Ref 10200164BModel 50 tests/kit
Identity
- Device Name
- Coxsackievirus A6/A10/A16 & Enterovirus 71 & Enterovirus Universal Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMED10200164B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795550634 EUDAMED
- Basic UDI-DI
- B-06974795550634 EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - 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
Coxsackievirus A6/A10/A16 & Enterovirus 71 & Enterovirus Universal Nucleic Acid… 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-06974795550634 | 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 117d909b-f454-4983-87bb-0d0945fbc8e0 61 fields · synced Jul 16, 2026