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Gene+Box Data Analysis and Management System
EUDAMEDClass A (EU MDR)
Ref ED5001Model Gene+Box
Identity
- Trade Name
- Gene+Box Data Analysis and Management System EUDAMED
- Device Name
- Gene+Box Data Analysis and Management System EUDAMED
- Model / Reference
- Gene+Box EUDAMEDED5001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975352996018 EUDAMED
- Basic UDI-DI
- 697535299BOX001QB EUDAMED
- EMDN Code
- W02050108 GENETIC SYSTEM READERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Gene+Box Data Analysis and Management System by Suzhou GenePlus Biomedical Engineering Co., Ltd. — Class A — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697535299BOX001QB | Class A | Active |
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Manufacturer
- Manufacturer
- Suzhou GenePlus Biomedical Engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000035774
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 34de57c2-e0c7-456c-9918-7fcb4995b234 61 fields · synced Jun 18, 2026