Devices (same UDI-DI)
2
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 80536089400968
- Basic UDI-DI Code
- 805360894ES000034X
- Reference
- ES00003-A
- 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 ES00003-A analyzer is a configurable device that is used for photometric analysis for qualitative and quantitative in-vitro determinations of human origin specimens. The Kit contains: Duo - Automated Immunochemistry Analyser ANL00003-A / Software Hi SFT-HI01-05 /Kit Accessories Duo ACC07108A-001A.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201010101 | CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) |
| W0201020103 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) |
Related Devices
The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).
Automatic Tissue Processor
Device
EU IVDR
·
Eu Ivd Class A
·Dakewe (Shenzhen) Medical Equipment Co., Ltd.·On the market·32 countries
CELL COUNTING INSTRUMENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·Zhuji Zhiwei Information and Technology Ltd.·On the market
Magnetic Immunoassay System
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen BOSH Diagnostics, Ltd.·On the market
ReaScan+
Device
EU IVDR
·
Eu Ivd Class A
·Reagena Oy·On the market·32 countries
Labtub
Device
EU IVDR
·
Eu Ivd Class A
·Lingen Precision Medical Products (Shanghai) Co., Ltd.·On the market
Labtub
Device
EU IVDR
·
Eu Ivd Class A
·Lingen Precision Medical Products (Shanghai) Co., Ltd.·On the market