Eu Ivdr
Eu Ivd Class A
On The Market
🇮🇹 Italy
Sphera - Automated Immunochemistry Analyser
Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 80536089401576
- Basic UDI-DI Code
- 805360894ES000014T
- Reference
- ANL00001-B
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Edif Instruments S.r.l.
Additional Description
The ANL00001-B module is a configurable device that is used in the ES00001-B medical device in combination with other accessories for photometric analysis for qualitative and quantitative in-vitro determinations of human origin specimens.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020102 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) |
| W0201010101 | CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) |
Related Devices
The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.
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