NAME OF DEVICE	FINGER OXIMETER
ESTABLISHMENT NAME	ROCKY SCIENTIFIC INSTRUMENTATION
ROLE OF ESTABLISHMENT	AUTHORIZED REPRESENTATIVE
REGISTRATION NO	GB7141125-211718
BRAND NAME	EDAN
MEDICAL DEVICE CATEGORY	MD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPE	SYSTEM
DEVICE DESCRIPTION	The H10 Finger Oximeter is a portable, non-invasive medical device designed for monitoring a patient's blood oxygen saturation level (SpO2) and pulse rate. It is intended for spot-checking oxygen saturation levels in both clinical and home environments. This device is particularly useful for patients with respiratory conditions or those undergoing oxygen therapy. The H10 is equipped with a built-in SpO2 measurement module and features a clear, easy-to-read OLED display screen that shows real-time oxygen saturation levels and pulse rate readings. The display is designed for high visibility even in low-light conditions. Included Accessories: Two (2) 1.5V AAA-size alkaline batteries for immediate use out of the box One (1) comprehensive user manual providing guidance on operation, maintenance, and troubleshooting
DEVICE INTENDED PURPOSE	The finger oximeter is intended for spot checking of functional oxygen saturation of arterial haemoglobin (%SpO2) and pulse rate (PR) for both adult and pediatric patients. It is indicated for use in medical institution and home environments.
VALIDITY DATE OF REGISTRATION	22/09/2025 - 21/09/2030