Eu Ivdr
Eu Ivd Class A
Not Intended For Eu Market
🇭🇺 Hungary
AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05999106200382
- Basic UDI-DI Code
- 59991062Icon5OPU7
- Reference
- NO50HD
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- Not Intended For Eu Market
- Manufacturer
- NORMA Instruments Zártkörűen Működő Részvénytársaság
Additional Description
Icon-5 OP is a 57 tests/hour laser and impedance based IVD hematology analyzer for laboratory use, using specific reagents, performing 5-part differential analysis of 27 parameters of anti-coagulated human whole blood samples introduced in open vials. Results are available in about a minute after initiating the measurement process.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0202010101 | AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) |
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.
Hemolyzer® 5 NG Open automated 5-part differential hematology analyzer with open sampling method
Device
EU IVDR
·
Eu Ivd Class A
·NORMA Instruments Zártkörűen Működő Részvénytársaság·On the market
Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method
Device
EU IVDR
·
Eu Ivd Class A
·NORMA Instruments Zártkörűen Működő Részvénytársaság·On the market
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