Vital Sign Monitoring - India CDSCO Medical Device Registration

Vital Sign Monitoring is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000366_22981315cdb7b71128191b1c5df5389b_adb5902b9656eba3fcae19b34c8a64ec. This device is marketed under the brand name Welch Allyn® Spot Vital signs 4400. The license holder is Maxlife Health Enterprises Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Vital Sign Monitoring

UID: IMP/MD/2021/000366_22981315cdb7b71128191b1c5df5389b_adb5902b9656eba3fcae19b34c8a64ec

Brand Name

Welch Allyn® Spot Vital signs 4400

License Holder

Maxlife Health Enterprises Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

The SPOT 4400 device is intended to be used by medical professionals for operator initiated spot-check/ single measurement of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (Welch Allyn® Spot Vital signs 4400), and body temperature in oral, rectal and axillary modes of adult and pediatric patients down to 29 days of age. The intended use locations for patients to be measured are physician’s offices, general hospital and alternate care environments