| Details of Equipment: |
 |
| Product Type: |
Blood Glucose Monitoring System |
| Brand Name: |
Onetouch |
| Model Number: |
Ultra Plus Flex |
| NCA Equipment No.: |
1R3-8H-7E1-0E8 |
| Product Name: |
Blood Glucose Monitoring System |
| Intended Use: |
In vitro diagnostic blood glucose monitoring device |
| Additional Details for Radio Equipment: |
| Frequency Range: |
BT: 2400-2483.5MHz |
| RF Output Power Radiation: |
|
| RF Output Power Conducted: |
-4.1dBm |
| RF Channel Spacing: |
2MHz (40 Channels) |
| RF Output Impedance: |
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| Type Of Modulation: |
GFSK |
| Bandwidth: |
|
| Software Version: |
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| Antenna Type: |
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| Antenna Gain: |
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| Technical Variants: |
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| Details of Certificate of Compliance: |
| Issuing Body: |
LifeScan Europe, Division of Cilag GmbH International |
| Issuing Date: |
13/06/2017 |
| Validity: |
Lifetime |
| Standards: |
| EMC: |
EN 301 489-1 V2.1.1
EN 301 4891-17 V3.1.1 |
| Radio: |
EN 300 328 V2.1.1 |
| Health And Safety: |
EN 62311:2008
EN 62479:2010
EN 62368-1:2014 |
| Manufacture's Information: |
| Name Of Manufacturer: |
LifeScan Europe, Division of Cilag GmbH International |
| Address Of Manufacturer: |
Gubelstrasse 34, 6300 Zug, Switzerland
|