Devices (same UDI-DI)
1
Certificates
0
Countries
5
Notified Bodies
0
Basic Information
- Primary DI
- 05714132000078
- Basic UDI-DI Code
- B-05714132000078
- Reference
- 60BB01
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Blusense Diagnostics ApS
Additional Description
BluBox is intended to be used by trained Healthcare Professionals in a laboratory environment and by Healthcare professionals in an in-door near-patient testing environment such as hospitals, clinics, pharmacies, long-term care facilities, primary care settings, or General Practitioners offices. BluBox is not intended to be used by lay users or at home. Training will be provided by the local representative/distributor of BluSense Diagnostics.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020101 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) |
Available In Countries
🇩🇪 Germany
🇩🇰 Denmark
🇮🇪 Ireland
🇮🇹 Italy
🇸🇪 Sweden
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