Blood Glucose Monitoring Meter
- UID
- MFG/IVD/2022/000050_d26b9fa6263a3bed1f3f1a1b83e0dbfd_3efb7c9a38c5827bf312d0a77b5d4b74
- Device class
- Class C
- Brand name
- Accu-Chek
- License holder
- Parekh Integrated Services Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, West Zone
- Product information
- Blood glucose meter is intended to be used for quantitative blood glucose tests in fresh capillary blood. The meter may only be used together with test strips. Consult the package insert of the test strips if you intend to use different sample material. The blood glucose monitoring system comprises the meter and test strips and is suitable for self-testing and for professional use. People with diabetes can use this system to self-test their blood glucose. Healthcare professionals can use this system to check patients’ blood glucose values and they can use it in suspected cases of diabetes and in emergency diagnostics. The system is suitable for testing blood glucose with blood obtained from alternative sites. The system must not be used to diagnose or rule out diabetes. The system is only suitable for use outside the body. Visually impaired persons must not use the meter. The system does not require a code chip.The meter must only be used for its intended purpose; if used otherwise preventive measures could be ineffective
Blood Glucose Monitoring Meter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000050_d26b9fa6263a3bed1f3f1a1b83e0dbfd_3efb7c9a38c5827bf312d0a77b5d4b74. This device is marketed under the brand name Accu-Chek. The license holder is Parekh Integrated Services Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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